• 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) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

LASIK Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Dry Eye(s) (1814); Blurred Vision (2137); Visual Impairment (2138); Halo (2227)
Event Date 10/23/2007
Event Type  Injury  
Event Description

Had lasik surgery done. I was told i was a good candidate, that i would have close to 20/20 vision, and that my focal point of sight would be about 14 inches from my eyes. They did mention complications, but told me that the possibility of having them was remote and had me sign a disclaimer waiving any possibility of holding them responsible if i had problems. My following check up showed my vision was not 20/20 and i was told my vision was better than they thought it would be. I was seeing as well as i did with my glasses, and i needed a stronger prescription when i went in. I now have severely dry eyes causing my eyes not only to be dry, but my nose now constantly runs. I not only see halos, but if i'm looking at a person sitting with their back to a window i can't see them- it's like they are sitting in a fog. My night vision is terrible, so much i don't drive at night unless i have to and only if i'm familiar with the route. I can't see anything up close and need reading glasses, and my point of focus is about 18 inches from my face, making the needlework i love to do extremely hard and tiring. I also see starbursts from any light source at night. (b)(6).

Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLASIK
Type of DeviceLASIK
MDR Report Key2016323
MDR Text Key16038917
Report NumberMW5019709
Device Sequence Number1
Product Code LZS
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 03/04/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/04/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator OTHER
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Is this a Reprocessed and Reused Single-Use Device? No

Date Received: 03/04/2011 Patient Sequence Number: 1