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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK SURGERY LASIK LASER SYSTEM

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LASIK SURGERY LASIK LASER SYSTEM Back to Search Results
Event Date 02/01/2013
Event Type  Other  
Event Description

Lasik surgery both eyes, no problems with pre procedure dry eyes. Now 16 months later, severe dry eye continues. I awaken with eye lids unable to open, sticking to eye ball, i require eye drops to separate eye ball from eye lids to open. I used eye drops all day long. My vision fluctuates all day long even with bilateral duct plugs.

 
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Brand NameLASIK
Type of DeviceLASER SYSTEM
Manufacturer (Section D)
LASIK SURGERY
MDR Report Key3885757
Report NumberMW5036680
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 06/14/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/16/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator Service Personnel

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