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Adverse Event Report

ALLERGAN AMO PHACOFLEX II SILICONE FOLDABLE IOL   back to search results
Model Number SI30NB
Device Problems Explanted; Lens, cloudy
Event Date 06/01/1999
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

Physician reported lens was removed and replaced one day post-operative due to his observation of lens clouding and pt's complaint of poor vision.

 
Manufacturer Narrative

Section f was completed by mfr. Eval summary: the returned lens was immersed in a solution of sterile water and evaluated utilizing a slit lamp. The lens displayed a haze level exceeding mfg specs. A review of the mfg data for this particular lens revealed no deviations during the process. The mfr's eval of this event is not yet complete.

 
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Brand NameAMO PHACOFLEX 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 drive
irvine CA 92612
Manufacturer (Section D)
ALLERGAN
2525 dupont drive
irvine CA 92612
Manufacturer (Section G)
A.M.O. PUERTO RICO MANUFACTURING, INC
rd. 402, km. 4.2
anasco PR 00610
Manufacturer Contact
grace kropidlowski
2525 dupont dr.-vk2a
irvine , CA 92713
(714) 246 -2300
Device Event Key223000
MDR Report Key229936
Event Key215850
Report Number2648035-1999-00006
Device Sequence Number1
Product CodeHQL
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 06/21/1999
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/28/1999
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date02/01/2004
Device MODEL NumberSI30NB
Device Catalogue NumberSI30NB
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/07/1999
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Device Age4 mo
Event Location Hospital
Date Manufacturer Received06/02/1999
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/01/1999
Is The Device Single Use? Yes
Is the Device an Implant? Yes
Is this an Explanted Device? Yes
Type of Device Usage Initial

Database last updated on February 28, 2009

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