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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
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
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Is This a Reprocessed and Reused Single-Use Device? No

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