Exposing the LASIK Scam

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PostPosted: Sun Oct 21, 2007 8:48 pm 
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The the FDA MedWatch adverse events database:

http://www.accessdata.fda.gov/scripts/c ... _ID=809132

Quote:
Pt was scheduled for bilateral lasik in 2002. Before her surgery, vision was 20/400 in the left eye and approximately 20/1600 in the right eye. The doctor began by performing the surgery on right eye. After preparing the eye for the surgery by applying numbing drops and using the wire lid speculum, he used a 130 micron moria microkeratome head. He examined the blade, placed it into the head of the microkeratome, and then screwed the head into the motor. Then, he tested the microkeratome on the suction ring. All of the equipment, including the motor, appeared to be in good working order. He then placed the suction ring on eye. Once the pressure was acceptable, he attached the microkeratome to the suction ring and made the cut. After he returned the microkeratome to its original position, he realized that the flap was a buttonhole. The doctor then inspected the microkeratome blade and head and did not find any damage. But, to be safe, the doctor replaced the blade and the motor. He again tested all of the equipment before he used the microkeratome to cut the corneal flap on the left eye. The flap in the left eye was a buttonhole as well. He did not perform laser treatment on either eye. The doctor sent pt home applying a bandage contact lens and prescribing a regimen of medicated drops. At the first post-operative visit on the next day, pt's vision was correctable to 20/60. Four days after the surgery, ptcame in for a second post-operative visit. The doctor noted that flaps were healing well but that the interface was irregular. Pt'svision was correctable to 20/40 in the right eye and 20/80 in the left. Pt did not visit the physician after the second post-operative visit and moria does not have any additional information about pt's condition. While the surgery took place in 2002, moria only learned of the surgery when pt's counsel recently contacted moria in connection with lawsuit against the surgeon who performed the lasik. After reviewing the records, moria decided to report this incident because it is an adverse event caused by user error. Pt had unusually steep corneas at 46 diopters which put them at special risk for buttonholes. The doctor did not properly account for the steepness of pt's corneas when he chose a microkeratome head that would have yielded a thinner cut. To prevent buttonholes, a physician should use a microkeratome head that would result in a thicker flap moreover, the buttonhole is not consistent with a malfunctioning motor or defective blade. Either of those problems would have led to a jagged cut rather than a buttonhole.

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PostPosted: Tue Nov 27, 2007 1:50 pm 
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Arch Ophthalmol. 2007 Nov;125(11):1515-22.
Surgical confusions in ophthalmology.
Simon JW, Ngo Y, Khan S, Strogatz D.
Department of Ophthalmology, Lions Eye Institute, Albany Medical College, Albany, 1220 New Scotland Rd, Ste 202, Slingerlands, NY 12159, USA. simonj@mail.amc.edu

OBJECTIVE: To investigate the hypothesis that surgical confusions rarely occur but are unacceptable to the public; occur in predictable circumstances; involve a wrong lens implant more often than a wrong eye, procedure, or patient; and can be prevented using the Universal Protocol.

METHODS: A retrospective series of 106 cases, including 42 from the Ophthalmic Mutual Insurance Company and 64 from the New York State Health Department. We investigated how the error occurred; when and by whom it was recognized; who was responsible; whether the patient was informed; what treatment was given; what the outcome and liability was; what policy changes or sanctions resulted; and whether the error was preventable using the Universal Protocol.

RESULTS: The most common confusion was wrong lens implants, accounting for 67 cases (63%). Wrong-eye operations occurred in 15 cases, wrong-eye block in 14, wrong patient or procedure in 8, and wrong corneal transplant in 2. Use of the Universal Protocol would have prevented the confusion in 90 cases (85%).

CONCLUSIONS: Surgical confusions occur infrequently. Although they usually cause little or no permanent injury, consequences for the patient, the physician, and the profession may be serious. Measures to prevent such confusions deserve the acceptance, support, and active participation of ophthalmologists.

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PostPosted: Fri Feb 08, 2008 10:52 pm 
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http://www.accessdata.fda.gov/scripts/c ... _ID=839944

Event Description
The dr reported that he was not able to hear the laser pulsing near the end of a therapeutic photokeratectomy procedure and believed that the laser had stopped firing. The laser did not display any errors and indicated in that the treatment completed successfully. Against the advice of amo's sr. Technical support engineer, the dr decided to continue with an add'l 18 seconds of treatment. At the one day post operative visit, the pt was 3. 0 diopter over corrected. Review of the equipment did not detect any malfunction.


Manufacturer Narrative
Evaluation: the machine operated as intended and completed the treatment. No errors were found on the error log and no evidence that the laser misfired. Review of the computer's hard drive revealed there to be no malfunction. The incident was determined to be due to the doctor's error.

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PostPosted: Sun Feb 17, 2008 10:26 pm 
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http://www.crstoday.com/PDF%20Articles/ ... 208_08.php

CASE PRESENTATION
A 26-year-old female presented for refractive surgery with no preexisting conditions. Her past medical and ocular history was uneventful. She sought to reduce her need for contact lenses. Her preoperative refractions were -3.75 +1.00 X 89 OD and -4.25 +1.25 X 75 OS. Preoperative ultrasound pachymetry measured corneal thicknesses of 567 ?m OD and 572 ?m OS.

The surgeon created the LASIK flap with the IntraLase FS laser (Advanced Medical Optics, Inc., Santa Ana, CA) set at 110 ?m. Intraoperative pachymetry measured 460 ?m OD and 466 ?m OS. The LASIK procedure was seemingly uneventful.


On the first postoperative day, the patient's visual acuity measured 20/20 OD with a residual refractive error of plano. The vision in her left eye was blurry with a visual acuity of 20/80 and a residual refractive error of -1.50 +2.50 X 85. A review of the patient's surgical chart showed that the surgical plan for the patient's left eye was a treatment of -4.00 +1.00 X 155 and that an error in the axis accounted for her residual refractive error.

How would you handle this patient who is now concerned that her left eye does not see as well as her right?

Quote:
STEPHEN F. BRINT, MD
This case underscores the need for surgeons to double-check the written surgical plan against the patient's chart for every eye they treat (preferably with the help of an independent observer such as the laser technician or optometrist involved) before the patient enters the laser suite. Surgeons should verify that the written surgical plan matches what is entered into the laser while the patient is on the table.

The mistake in this case occurs more often than one would like to think. It is usually due to a transposition from plus to minus cylinder, depending on the laser. For that reason, I like when possible to refract eyes in minus cylinder and keep everything in that format to help prevent these mistakes. This case may represent an error in data entry, however, because the axis of the left eye entered into the laser was 155? rather than 75?.


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