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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 09/02/2002
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

Bad lasik. Unlike many others, i read everything my doctor gave me and much on the web. I was ready for the halos and starburst, but hopeful that they would not occur. Not only did i get the halos and starburst, but i also had two others, and one far worse problem that was never disclosed to me by my doctor. Lasik also can cause your near vision to become worse. Immediately after the surgery i needed my reading glasses. When i asked my doctor, he indicated, "oh yes, that sometimes happens" and explained the reason why. Would have been nice to know before the surgery. Far worse was a severe increase in floaters in one eye again never reported. It is so bad that i literally cannot see out of that eye at certain times, and even in the best of cases, it's like someone put a piece of wax paper in front of that eye. My surgeon was widely known and highly regarded even appearing on abc's 20/20 as a fixit of other people's problems, and he turned out to be a charlatan. Dates of use: 2002. Diagnosis or reason for use: see better.

 
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Brand NameLASIK SURGERY
Type of DeviceLASIK
Device Event Key1007541
MDR Report Key1037822
Event Key996191
Report NumberMW5006602
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 05/01/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/01/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was The Report Sent To Manufacturer? No
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?

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