RENUADVANCEDFORMULAMULTI-PURPOSESOLUTION

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-03-02 for RENUADVANCEDFORMULAMULTI-PURPOSESOLUTION manufactured by Bausch & Lomb Incorporated.

Event Text Entries

[101375210] The complaint sample was not returned for evaluation and the product lot number was not provided. Additional information has been requested but has not been received. Based on available information, no causal factors can be determined and no conclusion can be drawn.
Patient Sequence No: 1, Text Type: N, H10


[101375231] A consumer reported, "y'all gave me ulcers in my eye" in response to a social media advertisement for the contact lens solution. No additional information was made available regarding the specific product (lot number), circumstances, or any associated medical evaluation/treatment. Additional information has been requested but has not been received.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001313525-2018-00055
MDR Report Key7309565
Report SourceCONSUMER
Date Received2018-03-02
Date of Report2018-02-03
Date Mfgr Received2018-02-03
Date Added to Maude2018-03-02
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
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
Manufacturer ContactMS. TES PROUD
Manufacturer Street1400 NORTH GOODMAN STREET
Manufacturer CityROCHESTER NY 14609
Manufacturer CountryUS
Manufacturer Postal14609
Manufacturer Phone5853388549
Manufacturer G1BAUSCH + LOMB
Manufacturer Street8507 PELHAM ROAD
Manufacturer CityGREENVILLE SC 29615
Manufacturer CountryUS
Manufacturer Postal Code29615
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameRENUADVANCEDFORMULAMULTI-PURPOSESOLUTION
Generic NameACCESSORIES, SOLUTION, CLEANERS FOR LENSES
Product CodeLYL
Date Received2018-03-02
ID NumberNI
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBAUSCH & LOMB INCORPORATED
Manufacturer Address1400 NORTH GOODMAN STREET ROCHESTER NY 14609 US 14609


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-03-02

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