BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATINUM 1 SERIES

    MDR report key: 6207513 · Received December 27, 2016

    Report

    Report Number
    2648035-2016-02096
    Event Type
    Malfunction
    Date Received
    December 27, 2016
    Date of Event
    December 2, 2016
    Report Date
    December 27, 2016
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    KYB
    UDI-DI
    05050474540323
    PMA / PMN Number
    K081545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LOT#: UNKNOWN/NOT PROVIDED. EXPIRATION DATE: UNKNOWN AS PRODUCT LOT NUMBER WAS NOT PROVIDED. IF IMPLANTED; GIVE DATE: N/A (NOT APPLICABLE).THE CARTRIDGE IS NOT AN IMPLANTABLE DEVICE. IF EXPLANTED; GIVE DATE: N/A (NOT APPLICABLE). THE CARTRIDGE IS NOT AN IMPLANTABLE DEVICE. DEVICE MANUFACTURE DATE: UNKNOWN AS PRODUCT LOT NUMBER WAS NOT PROVIDED. DEVICE EVALUATION: THE PRODUCT WAS DISCARDED BY THE CUSTOMER. THEREFORE, IT WAS NOT AVAILABLE FOR INVESTIGATION. THE REPORTED ISSUE WAS NOT VERIFIED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS AND COMPLAINT HISTORY FOR THE PRODUCT COULD NOT BE REVIEWED AS THE LOT NUMBER WAS NOT KNOWN. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WERE REVIEWED. THE DFU ADEQUATELY PROVIDE INSTRUCTIONS AND PRECAUTIONS ALONG WITH WARNINGS FOR THE PROPER USE AND HANDLING OF THE DEVICE. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A CARTRIDGE ERROR DURING HANDLING, BUT PRIOR TO INTRAOCULAR LENS (IOL) INSERTION. THE IOL WAS NOT IMPLANTED. THERE WAS NO PATIENT CONTACT. DURING FOLLOW-UP, IT WAS FOUND THAT THE CARTRIDGE WAS CRACKED UP TO THE TIP, DURING HANDLING BUT PRIOR TO IOL INSERTION. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855897 PLATINUM 1 SERIES SURGICAL ADJUNCTS KYB ABBOTT MEDICAL OPTICS 1MTEC30 UNKNOWN 05050474540323

    Patients

    Seq Age Sex Outcome Treatment
    1