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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK LASIK

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LASIK LASIK Back to Search Results
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem No Code Available (3191)
Event Date 01/01/2004
Event Type  Injury  
Event Description

I had lasik surgery for correction of shortsightedness. I did not realize if i was informed that i would need the preoperative measurements for subsequent cataract surgery. Now i am told this is a legal requirement from the dr, but he says the files are too difficult to retrieve and it is being done safely without. The surgeon i now see says there are limitations without these measurements and i am afraid to proceed. Is it possible to legally demand my records? is the lasik co required to maintain these records also? i see nothing about this problem on any forums or where i can get better info. I feel people are not truly aware of such difficulties in this subsequent but necessary and common surgery. Can you help me in any way? dates of use: (b)(6) 2004 - (b)(6) 2012. Reason for use: improve vision.

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Brand NameLASIK
Type of DeviceLASIK
Manufacturer (Section D)
MDR Report Key2557911
MDR Text Key19578585
Report NumberMW5025225
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
Type of Report Initial
Report Date 04/23/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/23/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Is this a Reprocessed and Reused Single-Use Device? No

Date Received: 04/23/2012 Patient Sequence Number: 1