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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 Failure to power-up
Event Date 09/04/2008
Event Type  Injury  
Manufacturer Narrative

The co service representative examined the system and confirmed the complaint. The backpanel board and laser engine were replaced to address the issue. The system was tested and met all product specifications. The backpanel board and laser engine were sent for in house testing. Investigation including root cause analysis is in progress. A supplemental mdr will be filed as necessary in accordance with 21 cfr 803. 56 when additional reportable info becomes available.

 
Event Description

The nurse reported the system could not be turned on. There was no screen display and the system was just clicking like it was trying to turn on. The co technical support specialist advised the nurse to recycle power and remove the ac cord from the adapter to the wall outlet. The nurse followed the troubleshooting recommendations but the problem still existed. The system seemed to be functioning properly first thing in the morning. The surgeon performed a cryopexy instead. Additional info rec'd from the surgeon stated the pt's outcome was poor. The surgeon noted the pt will need a posterior laser treatment.

 
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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 Key1186065
Report Number2028159-2008-00362
Device Sequence Number1
Product CodeHQF
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Nurse
Type of Report Initial
Report Date 09/04/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/03/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL Number8065500001
Device Catalogue Number8065500001
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer09/25/2008
Is The Reporter A Health Professional? Yes
Date Manufacturer Received09/04/2008
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/01/2004
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: 10/03/2008 Patient Sequence Number: 1
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