BIOTRUE ONE DAY

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-20 for BIOTRUE ONE DAY manufactured by Bausch & Lomb, Inc..

MAUDE Entry Details

Report NumberMW5089213
MDR Report Key8915582
Date Received2019-08-20
Date of Report2019-08-17
Date of Event2019-08-17
Date Added to Maude2019-08-21
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameBIOTRUE ONE DAY
Generic NameLENS, CONTACT, (DISPOSABLE)
Product CodeMVN
Date Received2019-08-20
Lot NumberW87228434
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerBAUSCH & LOMB, INC.


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-08-20

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.