BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOTRUE MULTI-PURPOSE SOLUTION(MILAN)

    MDR report key: 8186300 · Received December 20, 2018

    Report

    Report Number
    0001313525-2018-00242
    Event Type
    Injury
    Date Received
    December 20, 2018
    Report Date
    December 11, 2018
    Manufacturer
    BAUSCH & LOMB INCORPORATED
    Product Code
    LYL
    PMA / PMN Number
    K083757
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE LOT MANUFACTURING RECORDS AND TESTING OF RETAIN SAMPLES CONCLUDED THAT THE PRODUCT WAS FORMULATED, MANUFACTURED, AND PACKAGED ACCORDING TO LOCAL AND GLOBAL PRODUCT SPECIFICATIONS. THE SAUDI FDA REPORTED THAT ADDITIONAL INVESTIGATION AND TESTING OF BOTTLES FROM THE SAME LOT WERE PERFORMED AND CONCLUDED NO DEFECT FOUND. BASED ON ALL AVAILABLE INFORMATION, NO CAUSAL FACTORS CAN BE DETERMINED AND NO CONCLUSION CAN BE DRAWN.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT BEEN RETURNED AND NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. A REVIEW OF THE LOT MANUFACTURING RECORDS IS IN PROGRESS. BASED ON ALL AVAILABLE INFORMATION, NO CAUSAL FACTORS CAN BE DETERMINED AND NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    IT WAS REPORTED BY (B)(6) THAT A CONSUMER SUFFERED AN INFECTION AFTER APPLYING THE PRODUCT WHICH RESULTED IN THE CONSUMER BEING HOSPITALIZED. IT WAS ALSO REPORTED THAT (B)(6) OBTAINED THE PRODUCT FOR THEIR TESTING AND THE RESULTS DID NOT COMPLY WITH ISO 14729:2001. FURTHER MEDICAL INFORMATION SURROUNDING THE ADVERSE EVENT WAS REQUESTED AS WELL AS INFORMATION ON THE PRODUCT THAT WAS TESTED. ADDITIONAL INFORMATION HAS NOT BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1025144 BIOTRUE MULTI-PURPOSE SOLUTION(MILAN) ACCESSORIES, SOLUTION, CLEANERS FOR LENSES LYL BAUSCH & LOMB INCORPORATED MC1605

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization