BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATINUM 1 SERIES

    MDR report key: 5026161 · Received August 24, 2015

    Report

    Report Number
    2648035-2015-00691
    Event Type
    Malfunction
    Date Received
    August 24, 2015
    Report Date
    December 14, 2015
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    KYB
    PMA / PMN Number
    K081545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS OBTAINED FROM THE REPORTING FACILITY CONFIRMED THAT THERE WAS NO PATIENT CONTACT. REPORTEDLY, DURING HANDLING THE SURGEON NOTICED THE CARTRIDGE DID NOT LOOK RIGHT AND POSSIBLY HAVE A CRACK. THE SURGEON DECIDED TO USE A NEW LENS AND NEW CARTRIDGE. NO FURTHER INFORMATION WAS PROVIDED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    A PRODUCT COMPLAINT HISTORY REVIEW WAS PERFORMED. THE COMPLAINT PRODUCT HAS NOT BEEN RECEIVED AND THE LOT NUMBER COULD NOT BE OBTAINED; HOWEVER, BASED ON THE REVIEW OF ALL INFORMATION AVAILABLE, NO POTENTIAL PRODUCT DEFICIENCIES WERE IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CARTRIDGE CRACKED DURING INSERTION AND THERE WAS NO DELAY IN SURGERY. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557229 PLATINUM 1 SERIES SURGICAL ADJUNCTS KYB ABBOTT MEDICAL OPTICS 1MTEC30 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1