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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK PLUS LASIK LASIK EYE SURGERY

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LASIK PLUS LASIK LASIK EYE SURGERY Back to Search Results
Event Date 07/15/2011
Event Type  Injury  
Event Description

Had lasik eye procedure, performed at lasik plus in (b)(6). After one year, i have experienced chronic dry eye syndrome, to the point that my eyes are constantly red and dry and may require further surgery to correct this problem. Lasik eye surgery follow up dates: 1 week, 2 weeks, 3 weeks, one month, 3 months.

 
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Brand NameLASIK
Type of DeviceLASIK EYE SURGERY
Manufacturer (Section D)
LASIK PLUS
MO
MDR Report Key3229873
Report NumberMW5030868
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 07/10/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/10/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Service Personnel
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: 07/10/2013 Patient Sequence Number: 1
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