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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CUSTOMVUE VISX LASER CUSTOMVUE

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CUSTOMVUE VISX LASER CUSTOMVUE Back to Search Results
Lot Number 5057
Event Date 11/11/2010
Event Type  Injury  
Event Description

Bilateral lasik surgery to correct myopia and laser used was off center causing uneven cornea surfaces and warping of the cornea. Astigmatism, and dry eyes requiring prescription strength medication to correct. Note: on day of my surgery, the laser machine was sitting on a pallet jack. I did not see this but my husband did. He inquired about it and was told by one of dr. (b)(6) staff members, (b)(6), that it was ok sitting on the pallet jack. They left it there so they could load and unload it onto a truck to take to their other locations. (b)(6) told my husband that the laser machine constantly calibrated itself. Dr. (b)(6) (b)(6) 2010. Dr. (b)(6) (b)(6) 2010, dr. (b)(6) (b)(6) 2011.

 
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Brand NameCUSTOMVUE VISX
Type of DeviceLASER CUSTOMVUE
MDR Report Key2023576
Report NumberMW5019828
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 03/14/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/14/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device LOT Number5057
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 03/14/2011 Patient Sequence Number: 1
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