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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK

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LASIK Back to Search Results
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problems Dry Eye(s) (1814); Depression (2361)
Event Date 07/20/2011
Event Type  No Answer Provided  
Event Description
I had lasik on (b)(6) at laser vision (b)(6), the doctor was (b)(6).I was (b)(6).On (b)(6 ) 2014 i have been diagnosed with severe dry eye due to the surgery.I am on depression with suicidal thoughts.(b)(6).
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Brand Name
Type of Device
MDR Report Key3972765
MDR Text Key4754858
Report NumberMW5037511
Device Sequence Number1
Product Code LZS
Reporter Country CodeSP
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 07/27/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/28/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention; Disability;
Patient Age28 YR
Patient Weight50