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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNKNOWN LASIK

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UNKNOWN LASIK Back to Search Results
Lot Number UNKNOWN
Device Problem Insufficient Information (3190)
Patient Problems Visual Impairment (2138); Disability (2371)
Event Date 11/01/2000
Event Type  Injury  
Event Description

I am a physician in (b)(6). I was evaluated and felt to be a good candidate for lasik surgery in both eyes, with adequate corneal thickness. Within 2 years, i started noticing significant deterioration of my vision. I have been part of contact lens clinical studies, multiple refractions, and currently wear piggyback contacts in each eye in order to cope during the day. I am unable to drive at night and unable to wear glasses that will help to any degree. I have had to cut back my hours practicing as a physician as the reading and driving required are often prohibitive to me. I am now being evaluated for corneal transplant in both eyes. As a physician, i am appalled that this surgery was offered with this complication as a known outcome even for good candidates and am consistently appalled that it is advertised the way it is. I believe lasik should be withdrawn.

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Brand NameLASIK
Type of DeviceLASIK
Manufacturer (Section D)
MDR Report Key2321288
MDR Text Key2230182
Report NumberMW5022901
Device Sequence Number1
Product Code LZS
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 10/30/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/30/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator OTHER
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No

Date Received: 10/30/2011 Patient Sequence Number: 1