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Adverse Event Report

ALCON - IRVINE TECHNOLOGY CENTER SERIES TWENTY THOUSAND LEGACY OPHTHALMIC SURGERY SYSTEM   back to search results
Model Number STTL
Device Problem Burned
Event Date 04/17/2002
Event Type  Injury   Patient Outcome  Other;
Event Description

Rptr noted corneal burn occurred during procedure.

 
Manufacturer Narrative

A company service rep had checked the system previously and found it to meet its performance specs. Reviewed settings with customer.

 
Search Alerts/Recalls

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Brand NameSERIES TWENTY THOUSAND LEGACY
Type of DeviceOPHTHALMIC SURGERY SYSTEM
Baseline Brand NameSERIES TWENTY THOUSAND LEGACY
Baseline Generic NameOPHTHALMIC SURGERY SYSTEM
Baseline Catalogue NumberSTTL
Baseline Model NumberSTTL
Baseline Device FamilyPHACO
Baseline Device 510(K) NumberK911808
Baseline Device PMA Number
Baseline Shelf Life Information No
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed06/25/1991
Manufacturer (Section F)
ALCON - IRVINE TECHNOLOGY CENTER
15800 alton parkway
irvine CA 92618
Manufacturer (Section D)
ALCON - IRVINE TECHNOLOGY CENTER
15800 alton parkway
irvine CA 92618
Manufacturer Contact
charles dolbee
6201 south freeway
fort worth , TX 76134-2099
(817) 551 -8317
Device Event Key383770
MDR Report Key394759
Event Key372949
Report Number2028159-2002-00117
Device Sequence Number1
Product CodeHQE
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Remedial Action Other
Type of Report Initial
Report Date 04/17/2002
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/17/2002
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL NumberSTTL
Device Catalogue NumberSTTL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/17/2002
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Reuse

Database last updated on February 28, 2009

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