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Adverse Event Report

ALCON LABORATORIES, INC. / HUNGTINGTON ACRYSOF INTRAOCULAR LENS   back to search results
Model Number MA60BM
Device Problems Device remains implanted; Unknown (for use when the device problem is not known)
Event Date 11/06/2000
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

Additional info provided by the reporting surgeon indicates that the uveitis has improved rapidly. The surgeon states he feels there was no association between the event and the intraocular lens.

 
Event Description

A surgeon reported that one day following implantation of an intraocular lens (iol), the pt visited the hospital because of hyperemia. The surgeon diagnosed uveitis and observed an opaque area on the posterior side of the iol. The anterior side was clear. The lens remains implanted. The association between this event and the iol is not known. Additional information has been requested.

 
Manufacturer Narrative

F. : the info was supplied by the mfr, not the user facility. H. 3. , 6. : the complaint device has not been returned for evaluation. The device remains implanted. Product history records were reviewed, and all documents indicate the product met release criteria. There have been no other complaints for this lot.

 
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Brand NameACRYSOF
Type of DeviceINTRAOCULAR LENS
Baseline Brand Name1.INTRAOCULAR LENS
Baseline Catalogue NumberNA
Baseline Model NumberMA60BM
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. / HUNGTINGTON
6065 kyle lane
huntington WV 25702
Manufacturer (Section D)
ALCON LABORATORIES, INC. / HUNGTINGTON
6065 kyle lane
huntington WV 25702
Manufacturer Contact
timothy adkins
6201 south freeway
fort worth , TX 76134-2099
(817) 551 -8388
Device Event Key298145
MDR Report Key308161
Event Key289594
Report Number1119421-2000-01045
Device Sequence Number1
Product CodeHQL
Report Source Manufacturer
Source Type Foreign,Health Professional,User facility
Reporter Occupation Physician
Remedial Action Other
Type of Report Initial,Followup
Report Date 11/08/2000
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/08/2000
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date07/31/2001
Device MODEL NumberMA60BM
Device LOT Number403055
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/06/2000
Device Age4 yr
Event Location Hospital
Date Manufacturer Received11/08/2000
Was Device Evaluated By Manufacturer? No
Date Device Manufactured08/01/1996
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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