• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK SURGERY NONE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

LASIK SURGERY NONE Back to Search Results
Event Date 01/20/1998
Event Type  Injury  
Event Description

I have heard that the f. D. A. Is investigating lasik surgery and is interested in pts that have had unacceptable outcomes from lasik surgery. I had lasik surgery on both eyes approx ten yrs ago. Prior to surgery, i was extremely nearsighted. The surgery overcorrected my vision. In 1999, i went to another country for lasik to correct the now farsighted condition. I had surgery on my right eye at that time. The vision in my right eye is permanently distorted following that surgery. I was told that my condition was a "fluke" and they had no idea why my eye did not heal as expected. I now wear rigid contacts which corrects the irregular surface of my right eye and the farsightedness in my left. My uncorrected vision is improved from the original condition but not well enough to drive or do everyday tasks without contact lenses. The laser ctr.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLASIK SURGERY
Type of DeviceNONE
MDR Report Key1052136
Report NumberMW5007017
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 05/25/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/25/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 05/25/2008 Patient Sequence Number: 1
-
-