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

MAUDE Adverse Event Report: UNKNOWN LASIK

  • 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

UNKNOWN LASIK Back to Search Results
Lot Number UNKNOWN
Device Problem Insufficient Information (3190)
Patient Problems Visual Impairment (2138); Disability (2371)
Event Date 11/01/2000
Event Type  Injury  
Event Description
I am a physician in (b)(6). I was evaluated and felt to be a good candidate for lasik surgery in both eyes, with adequate corneal thickness. Within 2 years, i started noticing significant deterioration of my vision. I have been part of contact lens clinical studies, multiple refractions, and currently wear piggyback contacts in each eye in order to cope during the day. I am unable to drive at night and unable to wear glasses that will help to any degree. I have had to cut back my hours practicing as a physician as the reading and driving required are often prohibitive to me. I am now being evaluated for corneal transplant in both eyes. As a physician, i am appalled that this surgery was offered with this complication as a known outcome even for good candidates and am consistently appalled that it is advertised the way it is. I believe lasik should be withdrawn.
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLASIK
Type of DeviceLASIK
Manufacturer (Section D)
MDR Report Key2321288
MDR Text Key2230182
Report NumberMW5022901
Device Sequence Number1
Product Code LZS
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 10/30/2011
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/30/2011
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No

Patient Treatment Data
Date Received: 10/30/2011 Patient Sequence Number: 1