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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON - IRVINE TECHNOLOGY CENTER PUREPOINT LASER, OPHTHALMIC

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ALCON - IRVINE TECHNOLOGY CENTER PUREPOINT LASER, OPHTHALMIC Back to Search Results
Model Number PUREPOINT
Device Problem Device inoperable
Event Date 10/06/2008
Event Type  Injury  
Event Description

The nurse reported the sys worked fine for the first case. When turning the sys back on for the second case, the screen was black and the sys did not work. The surgeon switched to cryopexy to complete the case. No pt injury was reported.

 
Manufacturer Narrative

The returned sys was visually inspected with no non-conformities noted. The sys was turned on, but did not boot-up completely, showing a black screen. Further testing found the file sys within the flash memory was not functioning (corrupted). The non-functioning file sys was then deleted. When the file sys is not present, the kernel within that sys automatically rebuilds the file sys. The sys was then tested and met all prod specs. A review of the last 24 months revealed no complaints or svc requests related to the reported event.

 
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Brand NamePUREPOINT
Type of DeviceLASER, OPHTHALMIC
Manufacturer (Section D)
ALCON - IRVINE TECHNOLOGY CENTER
15800 alton pkwy.
irvine CA 92618
Manufacturer (Section G)
ALCON - IRVINE TECHNOLOGY CNETER
15800 alton pkwy.
irvine CA 92618
Manufacturer Contact
charles dolbee
6201 s. freeway r7-18
forth worth , TX 76134
8175518317
MDR Report Key1221256
Report Number2028159-2008-00403
Device Sequence Number1
Product CodeHQF
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Nurse
Type of Report Initial
Report Date 10/07/2008
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? Yes
Device Operator Health Professional
Device MODEL NumberPUREPOINT
Device Catalogue Number8065750597
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer10/15/2008
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received10/06/2008
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/01/2008
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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