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

MAUDE Adverse Event Report: LASIK

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

LASIK   Back to Search Results
Event Date 11/07/2007
Event Type  Injury   Patient Outcome  Other
Event Description

I had custom intralase lasik in 2007. My vision in my left eye was 20/40 after surgery. I had an enhancement done in seven months later on my left eye. Several weeks after enhancement, i noticed floaters in both eyes but especially in my left eye. These have not improved in the 6 months or so after my enhancement. These floaters consume most of my waking thoughts. I have researched for hours to find out there is nothing that can be done about them. They have caused me enormous stress and depression. I have a hard time with the thought that i will have to live with these forever. When i had the surgery, there was never any mention of floaters in the papers that i signed. I realize i took a risk having surgery, but is it possible that a study could be done to determine if floaters are indeed caused by lasik? there are so many people that have floaters that are struggling to cope with this garbage in their eyes. I know it is not a life threatening condition but i know that quality of life is definitely diminished. Please take this seriously. I would go back to my glasses days in a heartbeat ! !.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Type of DeviceLASIK
Device Event Key1006489
MDR Report Key1037657
Event Key996028
Report NumberMW5006564
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 Service Personnel
Is The Reporter A Health Professional? No
Was The Report Sent To Manufacturer? No
Is the Device an Implant? No
Is this an Explanted Device?

-
-