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Adverse Event Report

ALLERGAN OPTICAL ALLERGAN CUP CONTACT LENS CARE PRODUCT   back to search results
Event Type  Malfunction  
Event Description

The mfr of a contact lens care cup for use with 3 percent hydrogen peroxide systems received a report that a cup burst during use. No injury occurred. The mfr is implementing corrective actions to prevent reoccurrence of this event.

 
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Brand NameALLERGAN CUP
Type of DeviceCONTACT LENS CARE PRODUCT
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
ALLERGAN OPTICAL
8301 mars drive
waco TX 76712
Manufacturer (Section D)
ALLERGAN OPTICAL
8301 mars drive
waco TX 76712
Manufacturer (Section G)
ALLERGAN, INC.
2525 dupont dr.
irvine CA 92612
Device Event Key47863
MDR Report Key47059
Event Key44105
Report Number2011068-1996-00001
Device Sequence Number1
Product CodeLYL
Report Source Manufacturer
Source Type Consumer
Reporter Occupation NO INFORMATION
Type of Report Initial
Report Date 08/05/1996
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/31/1996
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Other
OTHER Device ID NumberNI
Was Device Available For Evaluation? Device Returned To Manufacturer
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date08/05/1996
Device Ageunknown
Event Location Home
Date Manufacturer Received08/05/1996
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 Unkown

Database last updated on January 06, 2009

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