FLUOROCON 8.07/9.5 DIAM -3.00 DIOPTER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-03-30 for FLUOROCON 8.07/9.5 DIAM -3.00 DIOPTER manufactured by Pilkington Barnes Hind, Inc..

Event Text Entries

[21693966] This lens was never disposed to the pt. Base curve verification was 8/12 instead of 8/07, well beyond accepted tolerance of good mfg practices and ansi standards. This was supposed to have been re-inspected for accuracy before shipment. Corneal health could have been seriously compromised by this poor quality control
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1001326
MDR Report Key12404
Date Received1994-03-30
Date of Report1994-03-28
Date Added to Maude1994-03-31
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameFLUOROCON
Generic NameRIGID GAS PERMEABLE CONTACT LENS
Product CodeHPX
Date Received1994-03-30
Returned To Mfg1994-03-28
Model Number8.07/9.5 DIAM
Catalog Number-3.00 DIOPTER
Lot NumberORDER #4898938/001
Device Expiration Date1997-03-01
OperatorOTHER
Device AvailabilityR
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key12404
ManufacturerPILKINGTON BARNES HIND, INC.
Manufacturer AddressSUNNYVALE CA 94086 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1994-03-30

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