BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATINUM 1 SERIES

    MDR report key: 6027278 · Received October 13, 2016

    Report

    Report Number
    2648035-2016-01584
    Event Type
    Malfunction
    Date Received
    October 13, 2016
    Date of Event
    September 16, 2016
    Report Date
    November 16, 2016
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    KYB
    UDI-DI
    05050474540323
    PMA / PMN Number
    K081545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE AVAILABLE FOR EVALUATION? YES. RETURNED TO MANUFACTURER ON: 10/18/2016. DEVICE RETURNED TO MANUFACTURER? YES. DEVICE EVALUATION: THE CARTRIDGE WAS RETURNED AT THE MANUFACTURING SITE FOR EVALUATION. VISUAL INSPECTION AT 10X MICROSCOPE MAGNIFICATION SHOWED RESIDUES OF WHAT APPEARS TO BE OVD (OPHTHALMIC VISCOSURGICAL DEVICE) INSIDE THE CARTRIDGE TUBE, INDICATING THAT THE DEVICE WAS HANDLED AND PREPARED FOR SURGICAL USE. A CRACK WAS OBSERVED AT THE CARTRIDGE TUBE/TIP. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE INTRAOCULAR LENS WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. DURING THE MANUFACTURING PROCESS THE OPERATORS CHECK THE NECK, TUBE AND TIP AREAS FOR CRACKS. NO CRACKING OR STRESS MARKS ARE ALLOWED. THEY ALSO CHECK THE TIP FOR ANY MELTING, ROUGHNESS, DENT, BENT TIP OR SMASH CONDITION. A SEARCH REVEALED THAT NO ADDITIONAL COMPLAINTS FOR THIS ORDER NUMBER HAVE BEEN RECEIVED. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WERE REVIEWED. THE DIRECTIONS FOR USE (DFU) ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS ALONG WITH WARNINGS FOR THE PROPER USE AND HANDLING OF THE DEVICE. 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.

    Additional Manufacturer Narrative · 1

    IMPLANT DATE: IF IMPLANTED, GIVE DATE: NOT APPLICABLE AS THIS IS NOT AN IMPLANTABLE DEVICE EXPLANT DATE: IF EXPLANTED, GIVE DATE: NOT APPLICABLE AS THIS IS NOT AN IMPLANTABLE DEVICE INITIAL REPORTER FIRST AND LAST NAME: UNKNOWN, NOT PROVIDED. PHONE NUMBER: (B)(6). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON OPENING THE UNIT CARTON, THE TIP OF THE CARTRIDGE WAS NOTICED DEFORMED; THEREFORE THE SURGEON DID NOT USE IT. NO PATIENT CONTACT AND NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680428 PLATINUM 1 SERIES SURGICAL ADJUNCTS KYB ABBOTT MEDICAL OPTICS 1MTEC30 CB32511 05050474540323

    Patients

    Seq Age Sex Outcome Treatment
    1