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

MAUDE Adverse Event Report: LASIK 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 NONE Back to Search Results
Event Date 05/17/2008
Event Type  Injury  
Event Description

Approx 6 weeks after lasik surgery, i noticed that points of light at night are doubled -e. G. , instead of one red traffic light, i see two-. Surprisingly, i don't notice much of the haloing and starbursting that are usually described as lasik night vision problems. I have also noticed that i experience double vision in my right eye during the day time. This is most noticeable when trying to read a ruler or tape measure. All the graduation lines are doubled and i have to close my right eye to determine the correct measurement. I have also noticed a dramatic increase in the number and density of the vitreous opacitities -floaters- in my vision. This increase also occurred at approx 6 weeks post surgery.

Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLASIK
Type of DeviceNONE
MDR Report Key1230095
Report NumberMW5008966
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 11/12/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/12/2008
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

Date Received: 11/12/2008 Patient Sequence Number: 1