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U.S. Department of Health and Human Services

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

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ALCON - ORLANDO TECHNOLOGY CENTER APEX PLUS EXCIMER LASER SYSTEM Back to Search Results
Catalog Number 8065325000
Device Problem Unknown (for use when the device problem is not known)
Event Date 01/01/1995
Event Type  Injury  
Manufacturer Narrative

Determination of root cause: assessment: investigation of the device could not be performed because no prod identification inf was provided. Non-prod factors including pt response to the laser ablation, pt healing characteristics and preoperative pt selection could not be reviewed because no pt specific/clinical records were provided for review. In addition, no specific info regarding the type of 'corneal problems' was provided. Conclusion: based on the limited info provided, a definitive root cause could not be determined for the reported event.

 
Event Description

A pt experienced corneal problems following refractive surgery. The pt considers the corneal problems were due to the surgery. No contact info was provided for either the surgeon or the pt, and no further info is available.

 
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Brand NameAPEX PLUS
Type of DeviceEXCIMER LASER SYSTEM
Manufacturer (Section D)
ALCON - ORLANDO TECHNOLOGY CENTER
2501 discovery dr.
orlando FL 32826
Manufacturer (Section G)
ALCON - ORLANDO TECHNOLOGY CENTER
2501 discovery dr.
orlando FL 32826
Manufacturer Contact
charles dolbee
6201 s. freeway r7y-18
fort worth , TX 76134
8175518317
MDR Report Key1221255
Report Number1061857-2008-00186
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type Other,Foreign
Reporter Occupation Unknown
Type of Report Initial
Report Date 10/06/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/05/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number8065325000
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received10/06/2008
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 Reuse

Patient TREATMENT DATA
Date Received: 11/05/2008 Patient Sequence Number: 1
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