BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILSOFT SUPER PLUS (ELASTOFILCON A) LENS

    MDR report key: 2801746 · Received October 12, 2012

    Report

    Report Number
    1313525-2012-00028
    Event Type
    Injury
    Date Received
    October 12, 2012
    Report Date
    October 4, 2012
    Manufacturer
    BAUSCH & LOMB
    Product Code
    LPM
    PMA / PMN Number
    P850068
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER IS UNKNOWN. THE EVENT OCCURRED IN A STUDY AND NO FURTHER DETAILS WERE PROVIDED. BASED ON ALL INFORMATION, NO CASUAL FACTORS CAN BE DETERMINED, AND NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    ARTICLE REFERENCED A PATIENT WHO WORE A SILSOFT SUPER PLUS CONTACT LENS ON AN OVERNIGHT BASIS AND DEVELOPED BACTERIAL KERATITIS. PATIENT RESOLVED WITHOUT SEQUELAE. NO FURTHER PATIENT INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILSOFT SUPER PLUS (ELASTOFILCON A) LENS LPM BAUSCH & LOMB

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention