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Adverse Event Report

ALCON - HOUSTON INFINITI VISION SYSTEM OPHTHALMIC SURGERY SYSTEM   back to search results
Model Number INFINITI
Device Problem Error message given
Event Date 03/24/2004
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

Reporter noted poor vacuum during phaco; error message received. Checked vacuum and changed cassette, with no improvement. Doctor was pushing lens nucleus with tip; zonules broken. Converted to ecce. Also noted they had re-used a single-use cassette pak.

 
Manufacturer Narrative

Received a cassette for evaluation. Visual inspection found no obvious defects. Passed all functional testing. Unable to duplicate performance problem reported.

 
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Brand NameINFINITI VISION SYSTEM
Type of DeviceOPHTHALMIC SURGERY SYSTEM
Baseline Brand NameINFINITI VISION SYSTEM
Baseline Generic NameOPHTHALMIC SURGERY SYSTEM
Baseline Catalogue Number8065750180
Baseline Model NumberINFINITI
Baseline Device FamilyPHACO
Baseline Device 510(K) NumberK021566
Baseline Device PMA Number
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed07/02/2002
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
forth worth , TX 76134-2099
(817) 551 -8317
Device Event Key512411
MDR Report Key523282
Event Key496645
Report Number1644019-2004-00014
Device Sequence Number1
Product CodeHQC
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Remedial Action Other
Type of Report Initial
Report Date 03/24/2004
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/30/2004
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL NumberINFINITI
Device Catalogue Number8065750181
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/12/2004
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/24/2004
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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