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Adverse Event Report

ALCON LABORATORIES, INC./HUNTINGTON ACRYSOF INTRAOCULAR LENS   back to search results
Model Number SA60AT
Device Problems Lens (IOL), dislocated intraocular; Lens replacement
Event Date 10/25/2002
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

A surgeon reports that the day following intraocular lens implant surgery, the intraocular lens (iol) had shifted. The lens was removed and replaced. Additional information has been requested.

 
Manufacturer Narrative

H. 3. , 6. : evaluation summary: the returned intraocular lens was evaluated and signs of handling during surgery were observed. Half of the optic and one haptic were received taped to a blue piece of cloth-like paper. The portion of the lens that was examined was dimensionally acceptable using an approved template. Product history records were reviewed and all documents indicate the product met release criteria. There have been no other complaints received for this lot.

 
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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 lane
huntington WV 25702
Manufacturer (Section D)
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 Key419202
MDR Report Key430215
Event Key407010
Report Number1119421-2002-00468
Device Sequence Number1
Product CodeHQL
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Remedial Action Other
Type of Report Initial
Report Date 10/28/2002
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/27/2002
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date06/30/2006
Device MODEL NumberSA60AT
Device LOT Number654004
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/12/2002
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received10/28/2002
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/01/2001
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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