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Adverse Event Report

ALCON LABORATORIES, INC./HUNTINGTON ACRYSOF INTRAOCULAR LENS   back to search results
Model Number SA60AT
Device Problem Lens (IOL), torn, split, cracked
Event Date 03/25/2003
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

Two nurses at the user facility report that damage was noted on the intraocular lens (iol) following insertion. Enlargement of the incision was required to accomodate removal and replacement. Another lens was implanted with a good outcome.

 
Manufacturer Narrative

Eval summary: the returned intraocular lens (iol) was examined and verified to have signs of handling. Both haptics were broken in the distal area (not returned) and the lens optic was torn/split/cracked on the post of the lens case. The optic also had scratches and was torn on the anterior surface. The iol was improperly re-cased by the customer, which may have contributed to the optic damage. The observations documented in this eval reasonably suggest that the damage occurred as the result of manipulation of the lens. There have been no other complaints reported for this lot number.

 
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Brand NameACRYSOF
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 ln
huntington WV 25702
Manufacturer (Section D)
ALCON LABORATORIES, INC./HUNTINGTON
6065 kyle ln
huntington WV 25702
Manufacturer Contact
timothy adkins
6201 south freeway
fort worth , TX 76134-2099
(817) 551 -8388
Device Event Key449797
MDR Report Key460855
Event Key436608
Report Number1119421-2003-00143
Device Sequence Number1
Product CodeHQL
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Nurse
Remedial Action Other
Type of Report Initial
Report Date 04/15/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/16/2003
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date11/30/2007
Device MODEL NumberSA60AT
Device LOT Number744263
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/17/2003
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/15/2003
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/01/2002
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 February 28, 2009

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