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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 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.
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Brand Name
Type of Device
Manufacturer (Section D)
MDR Report Key3164508
MDR Text Key18249512
Report NumberMW5030483
Device Sequence Number1
Product Code LZS
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
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age39 YR
Patient Weight52