Full text of DOI:10.1007/s12009-001-0066-1

A B S T R A C T
The Fugo Blade™ is a battery-powered electrosurgical device to
perform anterior capsulotomy for cataract surgery, employing an
incising filament as thick as a human hair. With this US Food and
Drug Administration-approved unit, surgeons can perform anterior
capsulotomy without the need of viscoelastic or a red reflex, as well
as enlarge the anterior capsulotomy with radial or arcuate incisions
into the capsulotomy margin. Multi-mini-sphincterotomies for small
pupils and iridotomies are off-label uses.
O R I G I N A L A R T I C L E
The Fugo Blade™:
The Next Step After Capsulorhexis
Richard J. Fugo & Dawn M. DelCampo
ver the last 30 years, great advancements have
been seen in the field of cataract surgery. Many of
O
the senior ophthalmic surgeons of today have seen
their cataract procedures change from intracapsular
cataract surgery to planned extracapsular cataract
surgery and most recently phacoemulsification
cataract surgery. Phacoemulsification itself has
changed dramatically with the introduction of tech-
nology such as viscoelastic solution and small suture-
less incisions with foldable implants. These changes
have improved the safety of surgery as well as the
capability of the surgeon. Nonetheless, there has been
a slowing of significant innovation over the last sever-
al years, possibly related to major cutbacks in reim-
bursement for cataract surgery and funds available to
perform research in our field.
Capsulorhexis versus Bipolar
Radiofrequency (RF) Capsulotomy
Early phacoemulsification and extracapsular cataract
extraction employed “Christmas tree” or “can-opener”
style capsulotomies. Over the last decade, this
approach has largely been supplanted by another
technique know as capsulorhexis capsulotomy. The
word capsulorhexis is derived from the Greek word
meaning “a tearing.” This technique employs a perfo-
ration of capsule followed by a maneuver to tear a cir-
cular or quasi-circular hole in the anterior capsule.1
The force vectors of a capsulorhexis tear are unpre-
dictable, often making the procedure difficult, and
capsulorhexis too frequently results in catastrophic
surgical complications.2-4
Reprints:
Richard J. Fugo & Dawn M. DelCampo, P.O. Box 1700, Norristown, PA 19404.
Both authors have a financial interest in this product.
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Fig 1.—Repairing a tear in lens capsule with the Fugo Blade™ capsulotomy device. Upper left: A keratome has just cut an oval tear in the capsule. Upper right: An incision has
just been made with the Fugo Blade™ in capsule perpendicular to the right side of the original keratome tear, and the Fugo Blade™ probe is about to put a similar incision on
the left side of the keratome tear. Lower left: A 30-gauge needle is placed through the original keratome capsule tear and is used to pull on the thin band of capsule between
keratome tear and the Fugo Blade™ incision on the right side. Lower right: The keratome hole in capsule tears up to but stops at the Fugo Blade™ margin.
Bipolar diathermy capsulotomies, although not
approved for marketing in the United States, are
employed by a substantial percentage of surgeons
throughout the world.5 Oertli of Switzerland has been
the most prominent manufacturer of bipolar
diathermy radiofrequency (RF) capsulotomy units.
This unit employs standard bipolar diathermy. It pro-
duces sufficient electrical current to pass through the
tip to cause a dielectric hysteresis, creating a heating
of capsule sufficient to burn a path through the cap-
sule. In effect, these units use the biologic tissue of
the capsule as a bioelectric resistor, which restricts
passage of the electrons through capsule material,
thereby generating heat. The problem with these
bipolar units is that they cut in an inefficient fashion
and often have their cutting tips stick to the capsule
surface. This problem is an innate limitation of a stan-
dard bipolar approach to electrosurgical capsulotomy.
Fig 2.—Four strands, visualized through an operating room microscope, lie across a
cornea, with the pupil margin seen superiorly. The 2 strands on the left are human
Therefore, these bipolar cutting tips must be used in a
very specific manner, namely, that they are moved in
a slow fashion and at a constant velocity.6 They also
require viscoelastic solution as a conductor path for
hairs. The third strand from the left is a pig hair. The strand on the far right is the
Fugo Blade™ incising filament.
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Fig 3.—When the Fugo Blade™ incising tip is activated, one may visualize the RF
energy field around the tip with an optically modified operating room microscope
(left). When one filters spurious light from around the activated tip, it is evident that
the energy field is closely compressed next to the incising filament (right).
Fig 4.—When one filters light to visualize the incising filament itself, the cutting fil-
ament itself remains dark while there is a glow around it, as seen under ultrahigh
magnification. This demonstrates a lack of blackbody glow from the tip, indicating
that the tip remains cool (left). The amount of energy visualized around the cutting
tip appears substantial, yet small rechargeable batteries in the unit console can
power this unit for a total cutting time of about 1 hour (right).
Fig 5.—A 3-second Fugo Blade™ capsulotomy. Upper left: The capsulotomy begins at –09 seconds on the counter. Upper right: Half of the capsulotomy is performed after 1 sec-
ond (ie, –08 seconds on the counter). Lower left: The second half of the capsulotomy is performed in 2 seconds (–06 seconds on the counter). Lower right: A completed Fugo
Blade™ capsulotomy.
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Fig 6.—Fugo Blade™ capsulotomy. Upper left: The capsulotomy begins at 16 seconds on the video timer. Upper right: In a counterclockwise motion, the left half of the capsu-
lotomy is completed in 3 seconds (19 seconds noted on the timer). Lower left: The capsulotomy is completed in a total of 5 seconds (21 seconds on the video timer). Lower right:
The completed Fugo Blade™ capsulotomy.
electrons to pass from one of the bipolar tips to the
second bipolar electrode.
Although bipolar RF capsulotomy offers distinct
advantages, capsulorhexis produces the strongest cap-
sular rim of any technique employed today. The rea-
son and physiologic basis of the strength of the
capsule is controversial, and the data presented in the
literature to date are contradictory. Authors have indi-
cated that capsulorhexis provides full capsular
strength, whereas bipolar radiosurgical capsulotomy
produces a decrease in strength in the capsule rim.
Nonetheless, the data that are used to support these
contentions are even contradictory between authors,
and histologic techniques employed are highly sus-
ceptible to artifact.7-9
Fig 7.—Under very high microscopic magnification, holes about 100 µm (average
Histologic Studies on
diameter) are seen in the posterior capsule. These were created by momentarily
Anterior Capsulotomy Rims
touching the activated Fugo Blade™ tip against the posterior capsule. Note in the
lower right hole in the capsule, vitreous is slightly bulging through the hole but can-
The histologic studies of our research group do not
agree with classically accepted articles in the field. It
is our belief that much of what has been presented in
the past is heavily weighed with specimen artifact.
Techniques are available, however, which minimize
not pass through it because the hole aperture is too small. Also, these small capsule
openings made with the Fugo Blade™ will not spontaneously continue to tear.
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Fig 8.—Multi-mini-sphincterotomies (MMS) are used to enlarge the pupil diameter. This can be performed with vitrectomy scissors but requires costly equipment and requires
significant time. A Fugo Blade™ MMS is an off-label use, as it would be for an iridotomy. Upper left: Beginning of a Fugo Blade™ MMS. Upper right: After 11 seconds, 6 sphinc-
terotomy incisions have been made. Lower left: Progress with the MMS procedure after 21 seconds of surgical time. Lower right: Completed MMS procedure, which required
about 30 seconds. We are now ready to infuse viscoelastic solution into the anterior chamber to further dilate the pupil. Note that the effect would be more dramatic with a small-
er pupil diameter.
the issue of artifact from data collection of anterior
capsule histologic specimens.
™
Fugo Blade Capsulotomy
The Fugo Blade™ capsulotomy device is produced by
Medisurg Research and Management Corporation,
Norristown, Pennsylvania, USA. The unit is housed in
a 10 × 8 × 6-inch electronic console. The device has a
high-tech solid-state design and is powered by inter-
nally housed rechargeable batteries. The unit also
comes with an activation foot switch, an electromag-
netic shielded handpiece, and a recharger unit for the
rechargeable batteries. The unit can operate only from
the power of the internal rechargeable batteries since
switching the console button to the ON position will
simultaneously disconnect the unit from the wall
charger/transformer power. This feature provides ulti-
mate patient safety.
The electronic console has 2 settings to control cut-
ting characteristics: cutting intensity and cutting
power. Cutting power includes 3 levels: low, medium,
Fig 9.—When multi-mini-sphincterotomies (MMS) are performed properly, they pro-
duce excellent visualization during surgery as well as superb cosmetic appearance
postoperatively. This is a slit-lamp high-magnification view of a MMS several weeks
postoperatively.
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Fig 10.—To demonstrate the cutting efficiency of the Fugo Blade™, one may place several capsulotomies around each other. Upper left: A small central capsulotomy is created.
Upper right: A second capsulotomy is created around the first capsulotomy. Lower left: A third capsulotomy is being created in a counterclockwise fashion around the second
capsulotomy. Lower right: The third capsulotomy rim is seen after partial evacuation of corticonuclear material, with a small amount of residual cortex noted inferiorly.
and high. The cutting intensity is controlled with a
vernier control knob, which rates the cutting intensity
from 1 through 10. Any combination of cutting power
may be used with any level of cutting intensity; there-
fore, the number of combinations is quite extensive
since the cutting intensity has a linear control. Sur-
geons will find that different combinations of these 2
console factors will provide variations in cutting char-
acteristics. It has been our experience that surgeons
tend to prefer a combination of these 2 characteristics.
For example, one surgeon may prefer medium power
with a cutting intensity of 5. This surgeon preference
will emulate the surgeon preference now seen in pha-
coemulsification. For example, surgeons prefer vari-
ous combinations of phaco aspiration and phaco
vacuum settings.
The cutting handpiece is an ergonomically
designed handpiece the size of a large pencil. The dis-
tal end of the autoclavable handpiece possesses a non-
polar electrical connector into which one inserts a
disposable cutting tip. It is imperative that this cut-
ting tip be used in 1 procedure only. The unit hand-
piece with the disposable cutting tip should be kept
on the surgical field until the end of the case in the
event that a rent is created inadvertently in the cap-
sule and the surgeon wishes to employ the unit to per-
form a Fugo Blade™ repair of a capsular tear (Fig 1).
Nonetheless, at the end of each case, this tip must be
replaced in order to provide maximum cutting effi-
ciency. Many of the same reasons apply for single use
of the Fugo Blade™ disposable tip as are seen with
such devices as the phacoemulsification unit tip. To
ensure that the tips are not reused, the electrical con-
nector in the disposable tip contains an electrical pin
connector that is heat sensitive and which has an
operational temperature below that of standard auto-
clave or flash autoclave.
The disposable cutting tip contains a cutting fila-
ment at its very distal portion, which has the thickness
approximately equivalent to a human hair (Fig 2).
When the unit is activated by depressing the surgeon’s
foot switch, the electrical energy of the rechargeable
batteries is processed through the solid-state electron-
ics inside the unit console and is passed down the
cable of the handpiece and through the handpiece.
This energy is concentrated at the cutting filament tip.
ANN OPHTHALMOL. 2001;33(1)
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Fig 11.—A Fugo Blade™ capsulotomy is created in 3 seconds, followed by radial incisions to enlarge the capsulotomy. Top left: the capsulotomy begins at 16 seconds on the
counter. Top right: The capsulotomy is completed at 19 seconds on the counter. Bottom left: To enlarge the capsulotomy, radial incisions are placed at the 4-o’clock and 5-o’clock
positions along the capsulotomy margin. Bottom right: To further enlarge the capsulotomy, another radial incision is placed at the 7-o’clock position along the capsulotomy mar-
gin. Infusion of viscoelastic solution into the anterior chamber would now create a significant enlargement of the capsulotomy diameter.
The output power at the cutting tip is variable from
1.25 to 3.50 W of average output power. The operation
frequency is higher than in most electrosurgical units.
This signal, however, is highly modulated in order to
present efficient energy transfer at the cutting tip,
thereby producing efficient incision into capsule. The
efficiency of RF energy transfer at the cutting tip
allows one to visualize the energy field around the
hair-thin cutting filament under filtered, high-magni-
fication visualization (Figs 3 and 4). We refer to this vis-
ible energy field as a resonant energy maze.
The cutting capability of the Fugo Blade™ capsulo-
tomy unit is quite precise and efficient. The unit is
approved in the United States for anterior capsuloto-
my only (Figs 5 and 6). By momentarily and gently
touching the Fugo Blade™ incising tip against the cap-
sule, one can create microscopic pore openings in the
capsule (Fig 7). Any use of this device for such maneu-
vers as a multi-mini-sphincterotomy or an iridotomy
would be considered an off-label application in the
United States (Figs 8 and 9). Initially surgeons are
encouraged to produce a slow and careful capsuloto-
my in order to minimize any complication. Surgeons
are recommended to employ a capsulotomy time of
approximately 5 to 20 seconds. The unit is employed
by gently tracing over the location on the capsule in
which the capsulotomy is desired. There is no attempt
to physically tear or punch through or perforate the
anterior capsule. This unit is a highly efficient incis-
ing device (Fig 10). The capsulotomy need not be per-
formed in a single maneuver, wherein several arcuate
incisions in the capsule can intersect and thereby cre-
ate a capsulotomy. If the surgeon is not content with
the initial capsulotomy, then it is recommended that
the surgeon enlarge the diameter of the capsulotomy
with arcuate incisions around the capsule margin or
employ radial incisions into the capsule margin (Figs
11 and 12). Because the Fugo Blade™ capsulotomy rim
is not as strong as capsulorhexis, it is advisable to
avoid pulling a larger nucleus through a smaller cap-
sulotomy opening. Many surgeons have had problems
in the past with such a maneuver, and radial tears
have developed in a capsulorhexis. This problem will
be even more prominent should a surgeon attempt
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Fig 12.—The Fugo Blade™ may be used to enlarge the capsulotomy size. Top left: A radial incision was just placed at the 11-o’clock position along the capsulotomy, and is now
about to be placed at the 10-o’clock position. Top right: Radial capsulotomy incisions were placed at 10 o’clock and 11 o’clock, and now is about to be placed at the 8-o’clock
position. Lower left: Radial capsulotomy incisions were placed at the 6, 7, 8, 10, and 11-o’clock positions. We are about to place another radial capsule incision at the 12-o’clock
position. Lower right: Following radial capsule incisions, viscoelastic solution is infused into the anterior chamber, pushing the small capsule flaps outward. Notice that the cap-
sulotomy margin is now just inside of the pupil margin. Inside of the capsule margin, there are radial incisions in the cortex where the radial capsulotomy incisions were made.
pulling a larger nucleus through a smaller capsuloto-
my opening with the Fugo Blade™ capsulotomy rim.
Finally, it should be emphasized that being able to
perform an anterior capsulotomy without a red reflex
will present the surgeon with a great ability to control
difficult surgeries (Fig 13).
coelastic solution or a red reflex is not needed with
this device. It is advised, however, that the novice sur-
geon employ viscoelastic for maximum safety in sta-
bilizing the anterior chamber during the early
learning curve. In general, surgeons should feel com-
fortable with this unit after about 10 to 20 cases.
Although this unit greatly decreases the difficulty of
opening the capsule as well as enlarging the size of the
capsulotomy, it provides a capsulotomy opening
which is not as strong as that of capsulorhexis. There-
fore, treating this margin in a manner similar to a cap-
sulorhexis is not appropriate. It is much wiser to
enlarge the capsulotomy than to attempt to pull a larg-
er nucleus through a smaller capsulotomy opening
since this will most likely result in a tear of the capsu-
lar rim. It is thereby obvious that surgeons must retool
their mental approach toward cataract surgery when
employing the Fugo Blade™ capsulotomy unit. As
such, the authors suggest using less physical force in
removing cortex and nucleus while employing more
surgical finesse in removing cortex and nucleus
through capsulotomies created with the Fugo Blade™.
Conclusion
In conclusion, the Fugo Blade™ capsulotomy unit
employs a solid-state electronic system powered by
rechargeable batteries to provide maximum patient
safety. It allows the surgeon to perform anterior cap-
sulotomy in a safe and repeatable fashion in seconds.
It also allows the surgeon to easily and safely enlarge
the size of the capsulotomy. Should a surgeon inad-
vertently tear the capsule during the procedure, this
can be repaired by placing a Fugo Blade™ incision in
front of the dissecting head of the tear. Use of the unit
to perform multi-mini-sphincteroromies for small
pupils or iridotomies would be considered an off-label
use. As with phacoemulsification devices, the active
incising tip is a disposable, one-time use item. Vis-
ANN OPHTHALMOL. 2001;33(1)
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Fig 13.—Anterior capsulotomy performed without a red reflex. The Fugo Blade™ can also perform an anterior capsulotomy under air, balanced salt solution (BBS), or viscoelas-
tic solution. Here, the anterior capsulotomy is performed with a combination of BSS and air in the anterior chamber. Top left: A Fugo Blade™ capsulotomy is being performed in
a clockwise fashion. Top right: The capsulotomy continues, and one can see the slight granularity of the capsule margin just inside the pupil margin. Lower left: The capsuloto-
my continues with the cutting probe now under an air bubble. Lower right: The capsulotomy is complete but is difficult to visualize secondary to a lack of a red reflex. Note the
granular-appearing margin of the capsulotomy rim just within the border of the pupil margin.
5. Gassmann F, Schimmelpfennig B, Klöti R. Anterior capsulotomy
As technology changes, our approach to surgery must
also change.
by means of bipolar radio-frequency endodiathermy. J Cataract
Refract Surg. 1988;14:673–676.
6. Michel G, Pietrini P, Klöti RF. Capsulotomy [videotape]. Switzer-
Educational courses with surgeon certification will
be offered on use of the Fugo Blade™. More informa-
tion about the Fugo Blade™ may be found on its Web
site at www.fugoblade.com.
land: Oertli Company; 1994 (EDV 497).
7. Luck J, Brahma AK, Noble BA. A comparative study of the elastic
properties of continuous tear curvilinear capsulorhexis versus
capsulorhexis produced by radiofrequency endodiathermy. Br J
Ophthalmol. 1994;78:392–396.
8. Morgan JE, Ellingham RB, Young RD, Trmal GJ. The mechanical
properties of the human lens capsule following capsulorhexis or
radiofrequency diathermy capsulotomy. Arch Ophthalmol. 1996;
114:1110–1115.
References
1. Gimbel HV, Neuhann T. Development, advantages, and methods
of the continuous circular capsulorhexis technique. J Cataract
Refract Surg. 1990;16:31–37.
9. Krag S, Thim K, Corydon L. Diathermic capsulotomy versus cap-
sulorhexis: a biomechanical study. J Cataract Refract Surg. 1997;
23:86–90.
2. Krumeich JH, Daniel J. Blunt, bent needle for continuous curvi-
linear capsulorhexis. J Cataract Refract Surg. 1998;24:1180–1183.
3. Kellan R. How to avoid complications with hypermature cataracts.
Ophthalmology Times. 2000;25:8–9.
4. DuBosar R. Capsular tears are complex but various techniques
provide management options. Ocular Surgery News. 1999;17:33–34.
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