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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
Lot Number LASIK
Device Problem Insufficient Information (3190)
Patient Problems Dry Eye(s) (1814); Emotional Changes (1831); Pain (1994); Visual Disturbances (2140); Halo (2227); Depression (2361)
Event Date 07/23/2011
Event Type  Injury  
Event Description

Botched lasik surgery leads to halos, starbursts, dry eye, pain, depression, suicidal thoughts, and discomfort.

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Brand NameLASIK
Type of DeviceLASIK
Manufacturer (Section D)
MDR Report Key2190688
MDR Text Key18617079
Report NumberMW5021567
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 07/30/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/30/2011
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER
Device LOT NumberLASIK
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No

Date Received: 07/30/2011 Patient Sequence Number: 1