• 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

  • 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 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.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Type of DeviceLASIK SURGERY
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

Patient TREATMENT DATA
Date Received: 05/23/2008 Patient Sequence Number: 1
-
-