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Adverse Event Report

ALCON LABS, INC. / HUNTINGTON ACRYSOF INTRAOCULAR LENS   back to search results
Model Number SN60AT
Device Problems Lens replacement; Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

A surgeon reports a lens exchange was required due to an unexpected postoperative refraction. Additional info has been requested.

 
Manufacturer Narrative

H. 3. , 6. : the complaint device associated with this report has not been received for evaluation. Product history records could not be reviewed because the reporter did not provide a lens serial number, lot number, or any identification traceable to the manufacturing documentation.

 
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Brand NameACRYSOF
Type of DeviceINTRAOCULAR LENS
Baseline Brand NameACRYSOF
Baseline Generic NameINTRAOCULAR LENS
Baseline Catalogue NumberNA
Baseline Model NumberSN60AT
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
ALCON LABS, INC. / HUNTINGTON
6065 kyle lane
huntington WV 25702
Manufacturer (Section D)
ALCON LABS, 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
fort worth , TX 76134-2099
(817) 551 -8388
Device Event Key506985
MDR Report Key517950
Event Key491489
Report Number1119421-2004-00094
Device Sequence Number1
Product CodeHQL
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 02/26/2004
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/26/2004
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL NumberSN60AT
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/26/2004
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
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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