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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK SURGERY NONE

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LASIK SURGERY NONE Back to Search Results
Event Date 06/01/2001
Event Type  Injury  
Event Description

No dry eye experienced or diagnosed prior to lasik surgery. Immediate and lasting severe dry eye, with pain, irritation, redness after surgery. Continuous discomfort. Must wear eye goggles to use oven, clothes dryer, must use no fan or heat in car. Must stay out of moving and/or heated air and any dust or smoke, including rooms with a fireplace. No relief from drops, lubricant or steroid, or restasis. No relief from punctal plugs. No eye makeup or lotions can be used anywhere near eyes. Numerous returns to surgeon's office. Seen by another doctor each time. No relief.

 
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Brand NameLASIK SURGERY
Type of DeviceNONE
MDR Report Key1588686
Report NumberMW5014485
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 01/23/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/23/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Is The Reporter A Health Professional? Yes

Patient TREATMENT DATA
Date Received: 01/23/2010 Patient Sequence Number: 1
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