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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK

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LASIK Back to Search Results
Lot Number 00
Event Date 08/12/2003
Event Type  Injury  
Event Description

Had lasik eye correction surgery in 2003. Vision started to deteriorate a few years later requiring glasses. Left eye started to require high astigmatism correction -5- that i couldn't tolerate because of dizziness. In 2009, was diagnosed with ectasia of the left cornea for which i started wearing rigid gas permeable contact in the left eye with glasses for correction of the right eye. Had corneal collagen cross linking in (b)(6) because it has not been approved by the fda in the usa. Now having severe night vision problems including double vision and halos. (b)(6).

 
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Brand NameLASIK
Type of DeviceLASIK
MDR Report Key1950663
Report NumberMW5018787
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Physician
Type of Report Initial
Report Date 12/29/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/29/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device LOT Number00
OTHER Device ID Number00
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes

Patient TREATMENT DATA
Date Received: 12/29/2010 Patient Sequence Number: 1
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