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Adverse Event Report

ALLERGAN OPTICAL COMPLETE BRAND MULTI-PURPOSE SOLUTION CONTACT LENS CARE PRODUCT   back to search results
Lot Number 10B55
Event Date 09/01/1996
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

A male patient reported experiencing allergic conjunctivitis after using solution for 3 days. Patient sought medical attention from an ophthalmologist who reportedly treated his condition with tobradex. Patient has recovered.

 
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Brand NameCOMPLETE BRAND MULTI-PURPOSE SOLUTION
Type of DeviceCONTACT LENS CARE PRODUCT
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
ALLERGAN OPTICAL
8301 mars dr.
waco TX 76712
Manufacturer (Section D)
ALLERGAN OPTICAL
8301 mars dr.
waco TX 76712
Manufacturer (Section G)
ALLERGAN, INC.
2525 dupont dr.
irvine CA 92612
Device Event Key86826
MDR Report Key87684
Event Key82513
Report Number2011068-1997-00032
Device Sequence Number1
Product CodeLPN
Report Source Manufacturer
Source Type Consumer,Health Professional
Reporter Occupation NO INFORMATION
Type of Report Initial
Report Date 01/06/1997
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/30/1997
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device EXPIRATION Date05/31/1998
Device LOT Number10B55
OTHER Device ID NumberNI
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location Home
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 04/30/1997 Patient Sequence Number: 1
#TreatmentTreatment Date
1,RENU TYPE: NI, CAT, MOD, SER: NI LOT UNK NUMBEG.,
2,UNK CONTACT LENS MODEL NI, CAT NI, SER NI,LOT UNK,

Database last updated on January 30, 2009

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