BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENU MULTIPLUS MULTI-PURPOSE SOLUTION

    MDR report key: 2001638 · Received February 18, 2011

    Report

    Report Number
    1313525-2011-00002
    Event Type
    Injury
    Date Received
    February 18, 2011
    Date of Event
    December 17, 2010
    Report Date
    February 9, 2011
    Manufacturer
    BAUSCH & LOMB
    Product Code
    LYL
    PMA / PMN Number
    K020802
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED AND EVAL RESULTS FOUND THE SOLUTION MET ALL CHEMICAL SPECIFICATIONS. MEDICAL DOCUMENTATION DOES NOT RELATE EVENT TO THE PRODUCT BUT RATHER TO ABUSE AND OVERWEAR OF THE CONTACT LENSES. PT WORE SAME PAIR OF LENSES FOR ONE YR AND SLEPT WITH THE LENSES. THE TYPE OF LENSES WORN IS UNK. BASED ON ALL INFO, NO CAUSAL FACTOR CAN BE DETERMINED AND NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    PT'S MOTHER REPORTED SON WAS DIAGNOSED WITH A BACTERIAL INFECTION IN BOTH EYES. F/U WITH THE TREATING DOCTOR CONFIRMED THE PT WAS DIAGNOSED WITH BILATERAL CENTRAL AND INFECTIOUS CORNEAL ULCERS AND TREATED WITH TOBRADEX FOR TEN DAYS. NO CULTURES WERE PERFORMED. PT RECOVERED WITH MULTIPLE CORNEAL SCARS. DOCTOR RELATED EVENT TO CONTACT LENS ABUSE AND OVERWEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENU MULTIPLUS MULTI-PURPOSE SOLUTION LYL BAUSCH & LOMB GB0043

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention UNK)| CONTINUOUS WEAR SOFT CONTACT LENSES (BRAND TYPE