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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNKNOWN LASER NONE

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UNKNOWN LASER NONE Back to Search Results
Event Date 12/20/2007
Event Type  Injury  
Event Description

Extreme dry eye - often unable to open eyes in morning without excruciating pain. Dose or amount: unknown. Dates of use: 2007 - 2008. Diagnosis or reason for use: reduce dependency on glasses/contact lense for left. Event abated after use stopped or dose reduced?: no. Unknown laser used to perform epilasik treatment; left eye treated in 2007, right eye treated in 2008.

 
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Brand NameUNKNOWN LASER
Type of DeviceNONE
MDR Report Key1515841
Report NumberMW5013149
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 10/21/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/21/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator OTHER
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 10/21/2009 Patient Sequence Number: 1
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