Exposing the LASIK Scam

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 Post subject: Oops, close calls, and near misses
PostPosted: Thu Jan 12, 2006 11:44 pm 
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Acta Ophthalmol Scand. 2003 Oct;81(5):530-2.


LASIK complication: loss of electricity to the microkeratome during the forward pass.

Tuominen IS, Tervo TM.

Department of Ophthalmology, Helsinki University Hospital, PO Box 220, HUS, SF-00029 Helsinki, Finland. ilpo.tuominen@hus.fi

CONTEXT: A 32-year-old woman was scheduled for myopic laser in situ keratomileusis (LASIK) because of myopia and anisometropia caused by retinal detachment surgery.

CASE REPORT: During surgery, a sudden malfunction of the microkeratome during the forward pass was experienced. It was not possible to reverse the blade manually along the suction ring. Moreover, disconnecting the suction from the control unit did not help at first, because the suction ring was firmly attached to the ocular surface. However, detaching the suction line from the control unit aborted the vacuum and allowed the surgeon to turn the whole microkeratome backwards, mimicking the normal blade movement. Finally, an almost normal flap was observed, and the operation was successfully completed. Afterwards, the wire to the electromotor of the microkeratome was found to be broken and subsequently replaced.

CONCLUSION: This type of unforeseen microkeratome malfunction may result in serious flap or other complications.

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PostPosted: Sat Jan 14, 2006 7:08 pm 
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What type of facility would use equipment with no power back up? No responsible doctor should have electrical surgical equipment with out a backup generator or a battery power back up. One never knows if there were a power surge or outage. I just thought that this was proper protocol. I'm having a surgical procedure this week and I'm certainly going to ask about back up power. Wonder if the FDA has regulations on equipment and possible power deficiencies.


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PostPosted: Sun Jan 15, 2006 1:05 pm 
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EyeWorld
January 2005

Lasers or surgeons:
What?s really the cause of high retreatment rates?


http://www.eyeworld.org/article.php?sid=2267

?I had one time where I had to put the flap back with a flashlight because the illumination light went off so I couldn?t figure out where the flap was,? Dr. Rubinfeld said.

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PostPosted: Mon Jan 16, 2006 3:00 am 
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Arch Soc Esp Oftalmol. 2005 Sep;80(9):547-9. Related Articles, Links

Refractive surprise after LASIK



CASE REPORT: A female patient underwent laser in situ keratomileusis (LASIK) in both eyes. The final degree of astigmatism in her left eye was double the preoperative value due to an error in data management. Complex surgery to both eyes was necessary to resolve the mistake. DISCUSSION: Complications in refractive surgery can occur, however errors in data management must be minimized by double-checking. Solutions to resolve the errors made can be difficult and the entire staff must share responsibility to avoid these undesirable outcomes.

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"The price good men pay for indifference to public affairs is to be ruled by evil men." Plato


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PostPosted: Mon Jan 16, 2006 3:56 am 
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J Cataract Refract Surg. 2002 Sep;28(9):1698-9.


Oculocardiac reflex in a nonsedated laser in situ keratomileusis patient.

Baykara M, Dogru M, Ozmen AT, Ozcetin H.

Uludag University Faculty of Medicine, Department of Ophthalmology, Bursa, Turkey

A healthy 21-year-old man had laser in situ keratomileusis (LASIK) in the right eye for a refractive error of -7.0 diopters. The electrocardiogram findings and heart rate were recorded before LASIK; during eye lid speculum insertion, vacuum application, corneal flap preparation, and excimer laser keratectomy; and after the procedure. The pre-LASIK heart rate was 90 pulses/min. Severe bradycardia of 40 beats/min developed during vacuum application, and the procedure was terminated. Severe bradycardia caused by an oculocardiac reflex may occur during LASIK, and patients should be closely monitored during the procedure.

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"The price good men pay for indifference to public affairs is to be ruled by evil men." Plato


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PostPosted: Mon Jan 16, 2006 4:10 am 
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Am J Ophthalmol. 2001 Nov;132(5):780-2.


Accidental self-removal of a flap--a rare complication of laser in situ keratomileusis surgery.

Sridhar MS, Rapuano CJ, Cohen EJ.

Cornea Service, Wills Eye Hospital, Jefferson Medical College of Thomas Jefferson University, Philadelphia, Pennsylvania, USA.

PURPOSE: To report a rare complication in which the patient accidentally removed the laser in situ keratomileusis corneal flap. METHODS: Interventional case report. A 35-year-old woman underwent uncomplicated laser in situ keratomileusis surgery. Ten days after surgery, she inserted a soft contact lens into the right eye to improve her vision. She tried to remove the contact lens, but had pain and bleeding. She was referred 10 days later with a diagnosis of loss of flap. RESULTS: On examination, she had a best-corrected visual acuity of 20/70 in the right eye. The right eye examination revealed no corneal flap, mild corneal edema, and significant haze. A central epithelial defect was found. CONCLUSION: Accidental corneal flap removal can rarely follow laser in situ keratomileusis surgery. This complication provides insight into the weak adhesion of the flap onto the stromal bed after laser in situ keratomileusis surgery and, hence, the inherent risk of traumatic flap dislocation or amputation, which needs to be explained to the patient.

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"The price good men pay for indifference to public affairs is to be ruled by evil men." Plato


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PostPosted: Mon Jan 16, 2006 4:12 am 
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J Cataract Refract Surg. 2001 Sep;27(9):1526-8.


Interface fluid after laser in situ keratomileusis.

Fogla R, Rao SK, Padmanabhan P.

Cornea Services, Sankara Nethralaya, Chennai 600 006, Tamil, Nadu, India. mrf@sankaranethralaya.org

We report a case in which raised intraocular pressure (IOP) was associated with interface fluid after uneventful bilateral laser in situ keratomileusis (LASIK). The patient presented with diffuse lamellar keratitis in both eyes 3 weeks postoperatively that was treated aggressively with topical corticosteroids. A steroid-induced rise in IOP resulted in interface fluid accumulation and microcystic edema. Measurements with the Goldmann tonometer revealed an IOP of 3.0 mm Hg in both eyes. However, Schiotz tonometry recorded a pressure of 54.7 mm Hg in both eyes. Reduction in the dosage of topical corticosteroid and medical treatment of the raised IOP resulted in resolution of the microcystic edema and interface fluid accumulation. This case highlights the inaccuracies of IOP measurement after LASIK and the resulting complications.

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"The price good men pay for indifference to public affairs is to be ruled by evil men." Plato


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PostPosted: Mon Jan 16, 2006 4:19 am 
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J Refract Surg. 2001 Mar-Apr;17(2 Suppl):S177-9.


Laser in situ keratomileusis: three unexpected complications.
Rosa DA.

PURPOSE: To report unexpected outcomes in three patients after uneventful laser in situ keratomileusis (LASIK) performed using the Nidek EC-5000 excimer laser and the Hansatome microkeratome (Bausch & Lomb Surgical). METHODS: LASIK was performed with the Nidek EC-5000 excimer laser and the Hansatome microkeratome (Bausch & Lomb Surgical) in three patients. RESULTS: In three patients, unexpected outcomes were observed. One patient treated for -3.00 D of myopia presented with a central island. One patient treated for +2.00 D (+1.00 x 90 degrees) of hyperopia in both eyes ended up emmetropic in one eye and overcorrected in the fellow eye. The third patient with -12.00 D (-2.00 x 180 degrees) of myopia was treated as -8.60 -1.00 x 180 degrees and at last examination was +4.00 D. During these sessions, all other patients treated were within +/-0.50 D of emmetropia. CONCLUSION: After LASIK with the Nidek EC-5000 excimer laser and the Hansatome microkeratome (Bausch & Lomb Surgical), unexpected outcomes may still occur, despite controlling all the usual variables.

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"The price good men pay for indifference to public affairs is to be ruled by evil men." Plato


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PostPosted: Tue Mar 28, 2006 1:33 am 
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http://www.osnsupersite.com/

TOP STORIES 3/24/2006

Failure to verify treatment parameters can lead to LASIK errors

Quote:
In the last case, the patient allowed the surgeon to call him ?Jos?? several times, believing the surgeon was making a joke. Only after one eye had been treated incorrectly did he clarify his name was ?Carlos,? Dr. Sonal said.

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PostPosted: Sun Nov 19, 2006 3:49 am 
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Not peer-reviewed, but it goes with this thread:

http://www.eyeworld.org/article.php?sid=3473

EyeWorld
November 2006

Fixing a lost or slipped flap

Quote:
?Lost flaps usually will occur in the operating room where the microkeratome just made too superficial a cut,? Dr. Geggel said. ?Surgeons have to be comfortable knowing how to take the microkeratome apart, because the lost flap is usually going to be somewhere within the machine.?

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PostPosted: Wed Apr 04, 2007 12:50 pm 
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From the FDA adverse events database:


http://www.accessdata.fda.gov/scripts/c ... _ID=795601

Model Number 0030-1479
Event Date 11/17/2006
Event Type Injury Patient Outcome Other;

Event Description

A programming error reportedly occurred resulting in the pt receiving an unexpected 5 diopters of astimagtism. The pt will be re-treated in two weeks which will correct the error. The surgeon reported that the laser worked perfectly.


Manufacturer Narrative
H3 & h6 - the equipment operated properly and no service was requested. The reporter indicated that the cause of the event was user error. No further evaluation of the equipment will be conducted.

-------------------------------------------------------------------------------

What moron surgeon thinks you can retreat 5 diopters of induced astigmatism in 2 weeks and "correct the error". I hope he got his butt sued off!

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"The price good men pay for indifference to public affairs is to be ruled by evil men." Plato


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 Post subject:
PostPosted: Thu Apr 05, 2007 6:19 pm 
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(non-peer reviewed)

http://www.ophthalmologytimes.com/ophth ... ?id=415978

"Dr. Maloney, director of the Maloney Vision Institute in Los Angeles, used a case report to illustrate the recommended treatment approach in response to ablation errors."

"He described a case involving a 23-year-old male with simple, myopic astigmatism who wanted to undergo LASIK (OD: ?0.37 ?4.62 X 08 ?20/20; OS: ?0.62 ?4.75 X 166 ?20/20). His cylinder reading put him outside of the range of custom ablation, in which it is nearly impossible to do an erroneous off-axis ablation, so he was scheduled to undergo conventional LASIK."

"As the surgeon and technician were preparing for the procedure, the laser inadvertently was programmed at axis 88 instead of axis 08."

?This is a typical error; a digit is dropped or added,? Dr. Maloney said. ?It?s typically 90? away where the axis error occurs, which maximizes the induced astigmatism.?

"As expected as a result of this error, the patient?s astigmatism had doubled from 4.62 to 9.5 D at a 2-week postoperative visit. His best-corrected visual acuity, however, was 20/20."


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PostPosted: Tue Aug 14, 2007 7:14 pm 
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http://www.crstoday.com/PDF%20Articles/ ... 807_03.php

"The surgeon planned a -6.00 D treatment for both eyes and programmed a Visx Star S4 laser (Advanced Medical Optics, Inc., Santa Ana, CA) for conventional bilateral LASIK. The ablation began on the patient's right eye after the uncomplicated creation of 75-?m-thick flap. Approximately 60% of the way through the ablation, the surgeon realized that the process was taking longer than expected. In addition, he noted that the fluorescence pattern of the ablation was in the peripheral cornea. The procedure was stopped. Upon close inspection of the entered parameters on the laser, the surgeon saw that +6.00 D had been inadvertently programmed for both eyes instead of -6.00 D. He aborted the original procedure after 568 of 968 pulses had been delivered to the peripheral cornea of the patient's right eye."


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PostPosted: Sun Aug 19, 2007 12:33 am 
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http://www.osnsupersite.com/view.asp?rID=23169

Eric D. Donnenfeld, MD:

Quote:
A 45-year-old woman came in for routine LASIK. I?m doing my LASIK, I hand off the keratome, and they blow out the keratome. And suddenly there is no flap. Now we?re looking for the flap, but we can?t find it. And all of you know how to find out if spaghetti is done. You throw it against the wall. If it sticks, it?s done. And that?s exactly what happened. The cornea ended up against the wall. We find it, but now it?s been sitting on the wall for about 5 minutes.

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"The price good men pay for indifference to public affairs is to be ruled by evil men." Plato


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 Post subject:
PostPosted: Sun Oct 14, 2007 9:42 pm 
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Not peer-reviewed, but it belongs here.

Excerpt from article about patient treated with a different patient's refractive error:

http://ophthalmology.stanford.edu/laser ... 241296.DTL

Quote:
After about an hour in the dark after her surgery, someone told Steward she could go home for the day, but to come back the next day for the standard post- operative followup check of her eyes. Davis tried to reassure her, Steward recalled, suggesting the extreme blurriness she was experiencing should clear up by the next morning.

She was given no explanation of what had happened, no hint of any glitches, even though Davis said he realized what had happened soon after the procedure was over. He just decided to keep it to himself for a while.

"I was absolutely in shock when I found out," he said. "I was going to tell her immediately, and then I consulted with another physician, who said the result 'may not be as bad as you think, so wait a little while, let it settle down. Fit her with contact lenses and make sure she's seeing well, and then talk about it.' "

"That was my big mistake," Davis said. "I should have told her right away."

Steward, unaware, didn't know enough to ask why she wasn't given a name tag to wear. Because she couldn't see the road, much less make out street signs, a friend drove her home, where she spent most of the day in bed, feeling her way around when she had to get up.

Her father took her back for the follow-up exam the next morning. She was more than a little upset. Even though she had been warned to expect some cloudy vision to persist for a while after the surgery, something just didn't seem right.

"My dad had to lead me by the arm into the doctor's office," Steward said. "He examined me, and said I had had an adverse reaction to the procedure. It was just something in the way my body reacted. He wouldn't explain it to me beyond that. He wanted to have me fitted for contacts. He just said the optometrist would fit me for contacts to try to get me to see better."

Davis knew exactly what had gone wrong. But he said he was hoping that Steward's eyesight would improve over time, or that another operation might be able to fix any residual defects.

Sometimes, a situation that looks like disaster may look much different as the eyes heal and the cornea gradually changes contour. Sometimes, even big overcorrections with a laser have a tendency to ease back toward normal on their own. And sometimes, even the stopgap measures don't work: Steward's eyes were in such bad condition it proved impossible even to make contact lenses work properly anymore.

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"The price good men pay for indifference to public affairs is to be ruled by evil men." Plato


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