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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK MACHINE

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LASIK MACHINE Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Cataract, Induced (1767); Therapeutic Response, Decreased (2271)
Event Date 01/01/2008
Event Type  Injury  
Event Description

I had lasik surgery in both eyes in 2008, had to have an enhancement in my left in 2013. My annual check up was this week and my eye doctor noted i now have cataracts developing in both eyes that were not there in 2009, 2013 before my enhancement or any of my checkups. I have development in the 6 yrs since my initial lasik. I am (b)(6) with no previous history of cataracts or medical reason for them to develop. (b)(6).

 
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Brand NameLASIK MACHINE
Type of DeviceLASIK
MDR Report Key4825141
MDR Text Key5840677
Report NumberMW5042971
Device Sequence Number1
Product Code LZS
Combination Product (Y/N)
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 05/29/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/29/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL

Patient TREATMENT DATA
Date Received: 05/29/2015 Patient Sequence Number: 1
Treatment
OTC MEDS: TYLENOL PM MELATONIN ALLEGRA; RX MEDS: TOPAMAX 100MG ATENOLOL 50MG
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