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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK CUSTUMVUE INTRA LASE

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LASIK CUSTUMVUE INTRA LASE Back to Search Results
Event Date 06/12/2008
Event Type  Injury  
Event Description

Had lasik in (b)(6) 2008 with refractive error of +725 in right eye and +525 in left eye. Had good initial vision, but had halos and starbursts at night. Year later, right eye regressed had enhancement. Helped a little. In 2011, right eye and left eye have slipped. I was told i would be able to wear contacts post lasik, but am unable to be fit with them. Eye exams are difficult due to the glares off of the snellen chart. What was supposed to make my life more convenient has done the opposite. Had surgery in (b)(6).

 
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Brand NameLASIK
Type of DeviceCUSTUMVUE INTRA LASE
MDR Report Key2220440
Report NumberMW5021803
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 08/17/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/17/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes

Patient TREATMENT DATA
Date Received: 08/17/2011 Patient Sequence Number: 1
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