BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATINUM 1 SERIES

    MDR report key: 6571160 · Received May 16, 2017

    Report

    Report Number
    2648035-2017-00864
    Event Type
    Malfunction
    Date Received
    May 16, 2017
    Report Date
    June 29, 2017
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    KYB
    UDI-DI
    05050474540323
    PMA / PMN Number
    K081545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE IS NOT AN IMPLANTABLE DEVICE; THEREFORE, NOT EXPLANTED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: MULTIFOCAL IOLS, SERIAL NUMBER: UNKNOWN. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. THE REPORTED COMPLAINT WAS NOT VERIFIED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATIONS. A SEARCH REVEALED THAT NO ADDITIONAL COMPLAINTS FOR THIS ORDER NUMBER HAVE BEEN RECEIVED. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WERE REVIEWED. THE DFU PROVIDE THE CUSTOMER WITH PROPER USAGE INSTRUCTIONS AND GUIDELINES. 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

    IT WAS REPORTED THAT THERE WERE DEPOSITS ON TWO INTRAOCULAR LENSES WHICH MAY BE VISUALLY SIGNIFICANT. THE CUSTOMER SUSPECTS THE PROBLEM IS WITH THE CARTRIDGE. THIS REPORT IS 1 OF 2. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352421 PLATINUM 1 SERIES SURGICAL ADJUNCTS KYB ABBOTT MEDICAL OPTICS 1MTEC30 CC01189 05050474540323

    Patients

    Seq Age Sex Outcome Treatment
    1