BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENU MULTIPLUS MULTI-PURPOSE SOLUTION

    MDR report key: 1937616 · Received December 20, 2010

    Report

    Report Number
    1313525-2010-00029
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Report Date
    November 29, 2010
    Manufacturer
    BAUSCH + LOMB
    Product Code
    LYL
    PMA / PMN Number
    K020802
    Removal / Correction Number
    PENDING
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    (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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENU MULTIPLUS MULTI-PURPOSE SOLUTION LYL BAUSCH + LOMB GH0066

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR