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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON VISX STAR S4 LASER

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ALCON VISX STAR S4 LASER Back to Search Results
Event Type  Injury  
Event Description

I had wave front lasik in (b)(6) 2010. My vision was corrected to 20/20 in right eye and to 20/25 in left eye after surgery. Immediately after surgery vision in my left eye got blurred. I am 9 months post op as of now, the vision in my left eye still same blurred. On top of it, two months after the surgery, i started developing floaters in both eyes. They just getting worse since then. Floaters extremely distracting during the day time, and on all bright backgrounds. Blurred vision in my left eye constantly distracting me while night driving. Since i can read 20/25 i am considered lasik success. This is no way how doctor can come up with such statements, i am suspecting that a lot of lasik "success" info is just simply misapprehended to public. I would like to get back to my glasses but no such way.

 
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Brand NameVISX STAR S4
Type of DeviceLASER
Manufacturer (Section D)
ALCON
MDR Report Key1964033
Report NumberMW5019027
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 01/11/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/11/2011
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

Patient TREATMENT DATA
Date Received: 01/11/2011 Patient Sequence Number: 1
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