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

MAUDE Adverse Event Report: LASIK 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 LASIK Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Cataract, Induced (1767); Visual Impairment (2138)
Event Date 01/22/2013
Event Type  Injury  
Event Description

I had lasik on both eyes in 2005 and developed cataracts in both eyes in 2011. I had cataract surgery in both eyes in 2013 as my vision was deteriorating rapidly. After both surgeries were complete, i was unable to see close up clearly and became extremely farsighted. I had to have a third surgery to implant a second lens in my left eye to correct the power. My doctor told me that this inability for an accurate measurement for iol after lasik was common. I am currently recuperating from this third surgery and am hoping for improved vision. I used the same doctor for both procedures. He was up front with me regarding the lasik as a potential cause of my cataracts. Dates of use: (b)(6) 2005. Reason for use: myopia.

Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLASIK
Type of DeviceLASIK
Manufacturer (Section D)
MDR Report Key3164508
MDR Text Key18249512
Report NumberMW5030483
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 06/06/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/06/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
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: 06/06/2013 Patient Sequence Number: 1