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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TECHNOLAS PERFECT VISION GMBH, HEADQUARTERS TECHNOLAS EXCIMER WORKSTATION EXCIMER LASER

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TECHNOLAS PERFECT VISION GMBH, HEADQUARTERS TECHNOLAS EXCIMER WORKSTATION EXCIMER LASER Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2006
Event Type  Injury  
Event Description

(b)(4). A pt reported undergoing lasik in both eyes in 2006 to treat nearsightedness (approx -4. 75 d). Postoperatively the pt reports having 20/20 vision, but the pt is dissatisfied because of continuing problems with halos, ghosting, dry eyes, and induced astigmatism. In addition, the pt reports experiencing poor night vision, loss of contrast, and loss of sharpness. The relationship between the event and the device is unk.

 
Manufacturer Narrative

The reporter did not provide contact info for f/u and the device serial number was not provided. Unable to perform a device eval or draw conclusions regarding root cause due to lack of info. Complaints of halos, dry eye, ghosting, induced astigmatism, poor night vision, loss of contrast/sharpness are known risks of lasik surgery and are identified in the device labeling. (b)(4).

 
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Brand NameTECHNOLAS EXCIMER WORKSTATION
Type of DeviceEXCIMER LASER
Manufacturer (Section D)
TECHNOLAS PERFECT VISION GMBH, HEADQUARTERS
messerschmittstr 1+3
munich 8099 2
GERMANY 80992
Manufacturer (Section G)
TECHNOLAS PERFECT VISION GMBH HEADQUARTERS
messerschmittstr 1+3
munich D-80 992
GERMANY D-80992
Manufacturer Contact
betty johnson
po box 17190
anaheim , CA 92817
7142738254
MDR Report Key2274714
Report Number3007606649-2011-00001
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type Other,Consumer
Type of Report Initial
Report Date 04/26/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/21/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Was Device Available For Evaluation? No
Date Manufacturer Received04/26/2010
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 09/21/2011 Patient Sequence Number: 1
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