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Adverse Event Report

ALCON LABORATORIES, INC./HUNTINGTON ACRYSOF INTRAOCULAR LENS   back to search results
Model Number MA60AC
Device Problems Unknown (for use when the device problem is not known); Implant, removal of
Event Date 05/26/2003
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

A surgeon reports that a pt developed endophthalmitis five days following intraocular lens (iol) implant surgery. The lens was removed and cultures of the lens were taken. Culture results were negative. The association between this event and the iol is not known.

 
Manufacturer Narrative

H. 3. , 6. : the complaint device associated with this report has not been received for eval. Product history records were reviewed and all documents indicate the product met release criteria. There have been no similar complaints received for this lot number.

 
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Brand NameACRYSOF
Type of DeviceINTRAOCULAR LENS
Baseline Brand Name1. INTRAOCULAR LENS
Baseline Catalogue NumberNA
Baseline Model NumberMA60AC
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 (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 Key483386
MDR Report Key494673
Event Key469026
Report Number1119421-2003-00375
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 09/17/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/07/2003
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date09/30/2007
Device MODEL NumberMA60AC
Device LOT Number733769
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received09/17/2003
Was Device Evaluated By Manufacturer? No
Date Device Manufactured10/01/2002
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 February 28, 2009

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