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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TLC LASER LASIK SURGERY LASER VISION CORRECTION

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TLC LASER LASIK SURGERY LASER VISION CORRECTION Back to Search Results
Event Date 02/21/2008
Event Type  Injury  
Event Description

After having lasik eye surgery, corneal ectasia has occurred, with decrease in vision prescription and starbursts and halo that make night vision extremely difficult. (b)(6).

 
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Brand NameLASIK SURGERY
Type of DeviceLASER VISION CORRECTION
Manufacturer (Section D)
TLC LASER
white plains NY
MDR Report Key1963737
Report NumberMW5019000
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 01/12/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/12/2011
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? Yes
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 01/12/2011 Patient Sequence Number: 1
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