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Adverse Event Report

ALLERGAN PHACOFLEX II SILICONE FOLDABLE IOL   back to search results
Model Number SI30NB
Device Problems Explanted; Lens, cloudy
Event Date 06/12/2001
Event Type  Injury  
Event Description

Physician observed a cloudy optic in an implanted lens at 1 day postop. Lens remains implanted.

 
Manufacturer Narrative

H. 6 - device remains implanted. Mfr will continue follow-up with physician.

 
Event Description

Lens removed and replaced due to the physician's observations of a cloudy optic.

 
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Brand NamePHACOFLEX II
Type of DeviceSILICONE FOLDABLE IOL
Baseline Brand NameAMO PHACOFLEX II
Baseline Generic NameINTRAOCULAR LENS
Baseline Catalogue NumberSI30NB
Baseline Model NumberSI30NB
Baseline Device FamilySILICONE IOLS
Baseline Device 510(K) Number
Baseline Device PMA NumberP880081
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)60
Date First Marketed06/01/1993
Manufacturer (Section F)
ALLERGAN
2525 dupont dr
irvine CA 92612
Manufacturer (Section D)
ALLERGAN
2525 dupont dr
irvine CA 92612
Manufacturer Contact
grace kropidlowski
2525 dupont drive
irvine , CA 92612
(714) 246 -2300
Device Event Key331643
MDR Report Key342307
Event Key322352
Report Number2648035-2001-00065
Device Sequence Number1
Product CodeHQL
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/11/2001
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/11/2001
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date06/30/2003
Device MODEL NumberSI30NB
Device Catalogue NumberSI30NB
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/12/2001
Device Age3 yr
Event Location AMBULATORY SURGICAL Facility
Date Manufacturer Received06/14/2001
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/01/1998
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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