FOCUS VISITINT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1998-05-18 for FOCUS VISITINT manufactured by Unk.

Event Text Entries

[20430502] Serious injury involving one person on 4/20/1998, pt mentioned to ciba consultant of inability to wear lenses due to ulcer in right eye, date of event: unk; lens model/water content: focus visitint/55%; eye involved: right; refraction: hyperopia; duration of use (months) wearing modality: 11; number of day lens worn: unk; lost visit to practitioner prior to symptoms: 5/1997; type of lens care system used: unk; name of disinfecting system used: unk; homemade saline used: no; number days worn between cleaning & disinfecting: unk; days between cleaning and symptoms: unk; days between symptoms and calling dr: not reported; self-treatment by pt: unk; hand washing before lens manipulation: unk; ulcer location: unk; visual acuity before symptoms: unk; visual acuity after symptoms; unk; results of culture: unk; results of corneal biopsy and/or scrapings: unk; clinical diagnosis: not reported; prognosis: based on consumer comments, she will resume lens wear.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9681121-1998-00009
MDR Report Key167777
Report Source05
Date Received1998-05-18
Date of Report1998-05-18
Date of Event1998-01-01
Date Mfgr Received1998-04-20
Date Added to Maude1998-05-19
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameFOCUS VISITINT
Generic NameSOFT CONTACT LENS
Product CodeLRX
Date Received1998-05-18
Model NumberNA
Catalog NumberNA
Lot Number7634014
ID NumberP820021
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key163237
ManufacturerUNK
Manufacturer AddressUNK UNK *
Baseline Brand NameFOCUS VISITINT
Baseline Generic NameSOFT CONTACT LENS
Baseline Model NoNA
Baseline Catalog NoNA
Baseline IDP820021


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1998-05-18

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