ALLERGAN CUP (GORETEX)

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04 report with the FDA on 2004-10-27 for ALLERGAN CUP (GORETEX) manufactured by Allergan, Inc..

Event Text Entries

[19250744] The manufacturer of a contact lens care cup for use with 3 percent hydrogen peroxide systems received a report from another country that a lens case exploded. No patient injury was reported. The lens cup is unavailable for evaluation.
Patient Sequence No: 1, Text Type: D, B5


[19343452] Cup unavailable for evaluation.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2020664-2004-00026
MDR Report Key903973
Report Source01,04
Date Received2004-10-27
Date of Event2004-07-06
Date Mfgr Received2004-07-06
Date Added to Maude2007-08-29
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Manufacturer ContactPAUL NOWACKI
Manufacturer Street1700 E. ST. ANDREW PLACE
Manufacturer CitySANTA ANA CA 92705
Manufacturer CountryUS
Manufacturer Postal92705
Manufacturer Phone7142478601
Manufacturer G1ALLERGAN
Manufacturer Street8301 MARS DRIVE
Manufacturer CityWACO TX 76712
Manufacturer CountryUS
Manufacturer Postal Code76712
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameALLERGAN CUP (GORETEX)
Generic NameCONTACT LENS CARE PRODUCT
Product CodeHRD
Date Received2004-10-27
Model NumberNA
Catalog NumberNA
Lot NumberNA
ID Number*
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrN
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key879005
ManufacturerALLERGAN, INC.
Manufacturer Address8301 MARS DRIVE WACO TX 76712 US


Patients

Patient NumberTreatmentOutcomeDate
10 2004-10-27

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