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U.S. Department of Health and Human Services

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

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ALCON - IRVINE TECHNOLOGY CENTER EYELITE LASER LASER INSTRUMENT, SURGICAL, POWERED Back to Search Results
Model Number EYELITE
Device Problem Fitting problem
Event Date 06/12/2008
Event Type  Malfunction  
Event Description

The customer reported the surgeon had a hard time getting the probe through the cannula. The surgeon was able to complete the case with no patient injury.

 
Manufacturer Narrative

The probe has been received for evaluation. Investigation including root cause analysis is in progress. A supplemental mdr will be filed as necessary in accordance with 21 crf 803. 56 when additional reportable information becomes available.

 
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Brand NameEYELITE LASER
Type of DeviceLASER INSTRUMENT, SURGICAL, POWERED
Manufacturer (Section D)
ALCON - IRVINE TECHNOLOGY CENTER
15800 alton parkway
irvine CA 92618
Manufacturer (Section G)
ALCON - IRVINE TECHNOLOGY CENTER
15800 alton parkway
irvine CA 92618
Manufacturer Contact
charles dolbee
6201 south freeway
fort worth , TX 76134-2099
8175518317
MDR Report Key1079110
Report Number2028159-2008-00263
Device Sequence Number1
Product CodeHQF
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 06/12/2008
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/11/2008
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL NumberEYELITE
Device Catalogue Number8065500001
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Date Manufacturer Received06/12/2008
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

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