RENU FRESH MULTI-PURPOSE SOLUTION

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2012-05-30 for RENU FRESH MULTI-PURPOSE SOLUTION manufactured by Bausch + Lomb.

Event Text Entries

[2786720] Doctor reported a pt presenting with eye pain in both eyes. Upon examination, pt was diagnosed and treated for corneal erosion. Three weeks later at a follow up visit, the corneal erosion was improved. The injury did not penetrate the bowman's membrane and there was no permanent decrease in visual acuity. There was a central corneal scar.
Patient Sequence No: 1, Text Type: D, B5


[9931802] The product was returned for eval and results found the solution met chemical specifications. Doctor did not relate the event to a specific product. Based on all info, no causal factor can be determined and no conclusion can be drawn.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1313525-2012-00013
MDR Report Key2596733
Report Source01,05
Date Received2012-05-30
Date of Report2012-04-27
Date of Event2012-04-15
Date Mfgr Received2012-05-21
Device Manufacturer Date2011-06-01
Date Added to Maude2012-06-05
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactMARLENE MARTRANO
Manufacturer Street1400 NORTH GOODMAN ST GLOBAL PRODUCT SURVEILLANCE
Manufacturer CityROCHESTER NY 14609
Manufacturer CountryUS
Manufacturer Postal14609
Manufacturer Phone5853388995
Manufacturer G1BAUSCH + LOMB
Manufacturer Street8507 PELHAM RD
Manufacturer CityGREENVILLE SC 29615
Manufacturer CountryUS
Manufacturer Postal Code29615
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameRENU FRESH MULTI-PURPOSE SOLUTION
Product CodeLYL
Date Received2012-05-30
Returned To Mfg2012-05-16
Lot NumberGE1134
Device Expiration Date2013-05-31
OperatorLAY USER/PATIENT
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBAUSCH + LOMB
Manufacturer AddressROCHESTER NY US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2012-05-30

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