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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VISX VISX CUSTOM LASIK

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VISX VISX CUSTOM LASIK Back to Search Results
Event Date 02/02/2007
Event Type  Injury  
Event Description

I am trying to get in touch with, whom i spoke with several months ago about this. I had lasik surgery on both eyes in 2007. Prior to going in for the surgery, i asked the lasik doctors there if i qualify. I didn't think i'd be eligible because my left pupil was overenlarged as a result of a head injury in 1985. That pupil never went back to its normal size. The lasik doctor told me "no problem" when i specifically asked her about the pupil size and whether it would make me ineligible for the surgery. She didn't blink an eye before responding, telling me it's not a problem at all. I was shocked. I thought, "great?" i had the surgery. The surgery resulted in a decentered ablation in my left eye. I've since learned that people with enlarged pupils shouldn't have the surgery. Is this true? what does the fda say about the screening process for potential lasik candidates? thanks in advance.

 
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Brand NameVISX
Type of DeviceCUSTOM LASIK
Manufacturer (Section D)
VISX
MDR Report Key1359009
Report NumberMW5010696
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 04/08/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/08/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator OTHER
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No

Patient TREATMENT DATA
Date Received: 04/08/2009 Patient Sequence Number: 1
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