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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON - ORLANDO TECHNOLOGY CENTER APEX OPHTHALMIC EXCIMER LASER SYSTEM

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ALCON - ORLANDO TECHNOLOGY CENTER APEX OPHTHALMIC EXCIMER LASER SYSTEM Back to Search Results
Device Problem Unknown (for use when the device problem is not known)
Event Date 10/07/1999
Event Type  Injury  
Manufacturer Narrative

Determination of root cause: assessment: a device eval could not be performed because no device identification info was provided. In addition, non-product factors could not be evaluated without pt's clinical records. The voluntary medwatch did identify multiple postoperative complications. Conclusion: with the limited info provided, a definitive root cause could not be identified.

 
Event Description

A voluntary medwatch was received from the fda. Info indicates a pt experienced difficulties, following bilateral lasik surgery. This report is for the right eye, the left eye is being submitted under mfr report #1061857-2008-00170. This pt reports experiencing blurry vision, halos, starbursts and dry eyes 4 months following initial lasik surgery. The following year an enhancement was performed on the right eye to address residual myopia and regression. Eight months later, a second enhancement was performed on the right eye, this is to correct residual myopia and astigmatism. This pt stated these surgeries resulted in decentered ablations, irregular astigmatism, dry eyes, blurred vision, halos, starbursts and loss of contrast. No further info is available.

 
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Brand NameAPEX
Type of DeviceOPHTHALMIC EXCIMER LASER SYSTEM
Manufacturer (Section D)
ALCON - ORLANDO TECHNOLOGY CENTER
2800 discovery dr.
orlando FL 32826
Manufacturer (Section G)
ALCON - ORLANDO TECHNOLOGY CENTER
2501 discovery dr.
suite 500
orlando FL 32826
Manufacturer Contact
charles dolbee
6201 south freeway
fort worth , TX 76134-2099
8175518317
MDR Report Key1119083
Report Number1061857-2008-00169
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type Other
Reporter Occupation Other
Type of Report Initial
Report Date 07/23/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/11/2008
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? No Answer Provided
Was the Report Sent to FDA? No
Date Manufacturer Received07/23/2008
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 08/11/2008 Patient Sequence Number: 1
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