BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOTRUE MULTI-PURPOSE SOLUTION

    MDR report key: 3855772 · Received April 21, 2014

    Report

    Report Number
    1313525-2014-00005
    Event Type
    Malfunction
    Date Received
    April 21, 2014
    Report Date
    April 14, 2014
    Manufacturer
    BAUSCH & LOMB
    Product Code
    LYL
    PMA / PMN Number
    K083757
    Removal / Correction Number
    1032500-04/21/2014-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED SAMPLE WAS TESTED AND FOUND TO EB OUT OF SPECIFICATION FOR ONE OF THE TWO DISINFECTANTS; POLYQUATERNIUM-1 (PQ-1) WAS NOT DETECTED.

    Description of Event or Problem · 1

    AS A RESULT OF A CONSUMER COMPLAINT, RETAIN SAMPLES OF TANK LOT JK3573 WERE TESTED AND CONFIRMED TO HAVE BEEN OUT OF SPECIFICATION (UNDETECTABLE) FOR ONE OF THE TWO DISINFECTANTS: POLYQUATERNIUM-1 (PQ-1). THE PQ-A SPECIFICATION IS (B)(4). PQ-1 ID TESTING DID SHOW PQ-1 TO BE PRESENT. DUE TO THE REMAINING 6 MONTHS OF THE 24 MONTH SHELF LIFE FOR FINISHED PRODUCT FILLED FROM TANK JK3573, THE DECISION WAS MADE TO RECALL THE ASSOCIATED FINISHED PRODUCT. THERE IS NO HEALTH HAZARD CONCERN AS THE OTHER DISINFECTANT WAS SHOWN TO BE AT THE PROPER LEVEL AND SHOWN THROUGH ADDITIONAL LABORATORY TESTING TO PROVIDE DISINFECTANT COVERAGE. THERE IS AN ON-GOING INVESTIGATION INTO THE ROOT CAUSE FOR THE OUT OF SPECIFICATION RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241358 BIOTRUE MULTI-PURPOSE SOLUTION CONTACT LENS MULTI-PURPOSE SOLUTION LYL BAUSCH & LOMB GK2127

    Patients

    Seq Age Sex Outcome Treatment
    1