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Adverse Event Report

ALCON LABORATORIES, INC./HUNTINGTON ACRYSOF INTRAOCULAR LENS   back to search results
Model Number SA30AT
Device Problem Haptic(s), broken
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

A nurse at the user facility reports that one of the intraocular lens haptics tore off during insertion. Enlargement of the incision was required to accomodate removal of the lens and an anterior vitrectomy was performed. Add'l info has been requested.

 
Manufacturer Narrative

Eval summary: the returned intraocular lens was examined and verified to have signs of handling. One haptic was broken in the gusset area and the other haptic was bent in the distal area. Co was unable to specifically identify the cause of the damage to this lens, however, the observations documented in this eval reasonably suggest that the damage occurred during manipulation of the lens during surgery. There have been no similar complaint reports received for this lot.

 
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Brand NameACRYSOF
Type of DeviceINTRAOCULAR LENS
Baseline Brand Name1. INTRAOCULAR LENS
Baseline Catalogue NumberNA
Baseline Model NumberSA30AT
Baseline Device FamilyIOL
Baseline Device 510(K) Number
Baseline Device PMA NumberP930014
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)60
Date First Marketed01/01/1979
Manufacturer (Section F)
ALCON LABORATORIES, INC./HUNTINGTON
6065 kyle lane
huntington WV 25702
Manufacturer (Section D)
ALCON LABORATORIES, INC./HUNTINGTON
6065 kyle lane
huntington WV 25702
Manufacturer (Section G)
ALCON LABORATORIES, INC./ HUNTINGTON
6065 kyle lane
huntington WV 25702
Manufacturer Contact
timothy adkins
6201 south freeway
forth worth , TX 76134-2099
(817) 551 -8388
Device Event Key438570
MDR Report Key449578
Event Key425714
Report Number1119421-2003-00083
Device Sequence Number1
Product CodeHQL
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Nurse
Remedial Action Other
Type of Report Initial
Report Date 02/19/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/21/2003
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date07/31/2006
Device MODEL NumberSA30AT
Device LOT Number658727
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/17/2003
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/19/2003
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/01/2001
Is The Device Single Use? Yes
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

Database last updated on January 30, 2009

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