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Adverse Event Report

ALCON LABORATORIES, INC./HUNTINGTON ACRYSOFT INTRAOCULAR LENS   back to search results
Model Number SA60AT
Device Problem Haptic(s), broken
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

A surgeon reports that during intraocular lens (iol) implant surgery, a haptic broke off while the lens was being inserted into the eye. The incision was enlarged to facilitate removal of the iol. Additional information has been requested.

 
Manufacturer Narrative

H. 3. , 6. : evaluation summary: the complaint sample was returned 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. The optic was torn/split/cracked into two pieces, possibly cut. While co is unable to specifically identify the cause of the damage to this lens, the observations documented in this evaluation reasonably suggest that the lens damage occurred during manipulation of the lens during surgery. There have been no other complaints reported for this lot of product.

 
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Brand NameACRYSOFT
Type of DeviceINTRAOCULAR LENS
Baseline Brand Name1. INTRAOCULAR LENS
Baseline Catalogue NumberNA
Baseline Model NumberSA60AT
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 LABRATORIES, INC.
6065 kyle la
huntington WV 25702
Manufacturer Contact
timothy adkins
6201 south freeway
fort worth , TX 76134-2099
(817) 551 -8388
Device Event Key417367
MDR Report Key428338
Event Key405224
Report Number1119421-2002-00452
Device Sequence Number1
Product CodeHQL
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Physician
Remedial Action Other
Type of Report Initial
Report Date 10/17/2002
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/18/2002
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 NumberSA60AT
Device LOT Number658897
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/21/2002
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received10/17/2002
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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