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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON - IRVINE TECHNOLOGY CENTER OPHTHALAS 532 EYELITE LASER SYSTEM LASER INSTRUMENT, SURGICAL, POWERED

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ALCON - IRVINE TECHNOLOGY CENTER OPHTHALAS 532 EYELITE LASER SYSTEM LASER INSTRUMENT, SURGICAL, POWERED Back to Search Results
Model Number 8065500001
Device Problem Device displays error message
Event Date 07/03/2008
Event Type  Malfunction  
Event Description

The customer initially reported a system message displayed, the system would not respond and one procedure had to be delayed. Additional information received in 2008, stated that the surgeon switched to cryopexy to complete the case. There was no patient injury reported.

 
Manufacturer Narrative

The company service representative examined the system and confirmed the reported event. The system message displayed occurs when the interlock jumper is not detected. It was determined in the field that the interlock jumper was removed by the facility bio-medical personal, and a new footswitch was inserted into the "interlock port" instead of the interlock jumper. The missing interlock jumper was then re-installed and the reported problem no longer occurred. The system was tested and met all product specifications. A review of complaints for the last 24 months did not indicate any additional reports for this system. This report was mailed to fda on: 08/21/2008.

 
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Brand NameOPHTHALAS 532 EYELITE LASER SYSTEM
Type of DeviceLASER INSTRUMENT, SURGICAL, POWERED
Manufacturer (Section D)
ALCON - IRVINE TECHNOLOGY CENTER
15800 alton pkwy.
irvine CA 92618
Manufacturer (Section G)
ALCON - IRVINE TECHNOLOGY CENTER
15800 alton pkwy.
irvine CA 92618
Manufacturer Contact
charles dolbee
6201 south freeway r7-18
fort worth , TX 76134
8175518317
MDR Report Key1134767
Report Number2028159-2008-00302
Device Sequence Number1
Product CodeHQF
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Nurse
Type of Report Initial
Report Date 07/03/2008
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/21/2008
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL Number8065500001
Device Catalogue Number8065500001
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Date Manufacturer Received07/07/2008
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/01/2006
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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