RENU MULTIPLUS MULTI-PURPOSE SOLUTION

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2010-12-20 for RENU MULTIPLUS MULTI-PURPOSE SOLUTION manufactured by Bausch + Lomb.

Event Text Entries

[1765751] (b)(6) fda reported a consumer complaint involving a (b)(6) male who experienced blurred vision, tearing, eye pain, and was taken to the er. Consumer was referred to an eye doctor who diagnosed and treated for corneal abrasions. Condition improved during the week. Consumer was wearing decorative contact lenses purchased off the shelf from a "(b)(6)". Consumer's mother who reported the event to fda requested confidentiality. (b)(6) fda reported to bausch + lomb that a modified bioburden test was performed on one sample from lot gh0066 and resulted in an observation of viable mold. This reported result indicates the potential for compromised package sterility. The mold species was not identified and a bausch + lomb investigation is ongoing.
Patient Sequence No: 1, Text Type: D, B5


[8809028] Product was not returned for eval. A review of the lot batch records and chemical testing of the retain sample showed all requirements were met.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1313525-2010-00029
MDR Report Key1937616
Report Source99
Date Received2010-12-20
Date of Report2010-11-29
Date Mfgr Received2010-11-29
Device Manufacturer Date2010-08-01
Date Added to Maude2011-01-19
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA0
Event Location0
Manufacturer ContactTES PROUD
Manufacturer Street1400 NORTH GOODMAN ST.
Manufacturer CityROCHESTER NY 14609
Manufacturer CountryUS
Manufacturer Postal14609
Manufacturer Phone5853388549
Manufacturer G1BAUSCH + LOMB
Manufacturer Street8507 PELHAM RD
Manufacturer CityGREENVILLE SC 29615
Manufacturer CountryUS
Manufacturer Postal Code29615
Single Use3
Remedial ActionRC
Previous Use Code3
Removal Correction NumberPENDING
Event Type3
Type of Report3

Device Details

Brand NameRENU MULTIPLUS MULTI-PURPOSE SOLUTION
Product CodeLYL
Date Received2010-12-20
Lot NumberGH0066
Device Expiration Date2012-08-31
OperatorLAY USER/PATIENT
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBAUSCH + LOMB
Manufacturer AddressROCHESTER NY US


Patients

Patient NumberTreatmentOutcomeDate
10 2010-12-20

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