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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK SURGERY

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LASIK SURGERY Back to Search Results
Event Date 08/02/2002
Event Type  Injury  
Event Description

Lasik surgery on both eyes. Problems: evaluation for candidacy did not include a thorough explanation of the effects of substituting distance vision for close vision in an older person. I was told that i would probably need reading glasses. Before the surgery, i was able to take off my glasses -which i had worn for myopia since age 8- and see up close. I was able to read, to put on makeup, to cut my toe nails, to see faces up close, to work on the computer - in short, the vast majority of activities that one does. I could not drive without my glasses or see distances. As a result of the surgery, i could drive and see distances, but 99% of my daily activities were now no longer available to me without reading glasses. In addition, i could not see as well with the reading glasses. I wore progressive lenses before; i wear progressive lenses today. Eight years later, i am still angry and mourn the loss of my vision every day. The issue is whether i was an appropriate candidate for this surgery in the first place.

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MDR Report Key1052143
Report NumberMW5007022
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 05/23/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/23/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Service Personnel
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No

Date Received: 05/23/2008 Patient Sequence Number: 1