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Adverse Event Report

ALCON - HOUSTON SERIES TWENTY THOUSAND LEGACY OPHTHALMIC SURGERY SYSTEM   back to search results
Model Number STTL
Device Problem Other (for use when an appropriate device code cannot be identified)
Event Date 07/13/2004
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

Reporter noted using system parameters for one type of cassette, unaware that cassette supply had changed. Anterior chamber collapsed, a little fragment of iris was aspirated, and posterior capsule rupture occurred. A vitrectomy was performed, but some fragments of nucleus remain in vitreous. Perfers to wait for eye to be calm before performing a second surgery. Corneal endothelium is damaged, but to a lesser extent than anticipated.

 
Manufacturer Narrative

Received a cassette for evaluation. No obvious defects found in visual inspection; met specifications in functional testing. Company rep confirms that facility had been notified of change, and that parameters would need to be revised. Two other surgeons performed surgeries without problem.

 
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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 - HOUSTON
2650 west bellfort
houston TX 77054 5008
Manufacturer (Section D)
ALCON - HOUSTON
2650 west bellfort
houston TX 77054 5008
Manufacturer (Section G)
ALCON - HOUSTON
2650 west bellfort
houston TX 77054 5008
Manufacturer Contact
charles dolbee
6201 south freeway
fort worth , TX 76134-2099
(817) 551 -8317
Device Event Key528478
MDR Report Key539190
Event Key511945
Report Number1644019-2004-00021
Device Sequence Number1
Product CodeHQE
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 07/13/2004
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/12/2004
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL NumberSTTL
Device Catalogue NumberSTTL
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/04/2004
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/13/2004
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Reuse

Database last updated on January 30, 2009

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