BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATINUM 1 SERIES

    MDR report key: 5524450 · Received March 24, 2016

    Report

    Report Number
    2648035-2016-00443
    Event Type
    Malfunction
    Date Received
    March 24, 2016
    Date of Event
    February 23, 2016
    Report Date
    June 13, 2016
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    KYB
    PMA / PMN Number
    K081545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE PRODUCT WAS RECEIVED AND IDENTIFIES THE MODEL OF THE CARTRIDGE, MODEL 1MTEC30. BRAND NAME: PLATINUM 1 SERIES, MODEL# 1MTEC30, CATALOG# 1MTEC30. DEVICE AVAILABLE FOR EVALUATION: YES. RETURNED TO MANUFACTURER ON: 03/21/2016. PMA/510(K)#: K081545. DEVICE RETURNED TO MANUFACTURER: YES. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    IF IMPLANTED; GIVE DATE: NA (NOT APPLICABLE) ;THE CARTRIDGE IS NOT AN IMPLANTABLE DEVICE. IF EXPLANTED; GIVE DATE: NA (NOT APPLICABLE; ) THE CARTRIDGE IS NOT IMPLANTED; THEREFORE, NOT EXPLANTED. PMA/510(K): UNKNOWN, BECAUSE PRODUCT MODEL IS UNKNOWN. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE CARTRIDGE WAS RETURNED AT THE MANUFACTURING SITE IN A PLASTIC BAG. VISUAL INSPECTION AT 10X MICROSCOPE MAGNIFICATION REVEALED EVIDENCE OF VISCOELASTIC RESIDUES, OVD (OPHTHALMIC VISCOSURGICAL DEVICE) IN THE CARTRIDGE TUBE, TIP, AND LOADING ZONE INDICATING THE SAMPLE WAS HANDLED AND PREPARED FOR SURGICAL USE. NO CRACKS DEFECT AT THE CARTRIDGE TUBE OR TIP SECTIONS WERE OBSERVED IN THE UNIT. THE CUSTOMER'S REPORTED COMPLAINT COULD NOT BE VERIFIED. MANUFACTURING RECORDS REVIEW: SINCE THE LOT NUMBER IS UNKNOWN THE MANUFACTURING RECORD EVALUATION COULD NOT BE PERFORMED. HOWEVER, DURING THE MANUFACTURING PROCESS THE OPERATORS CHECK THE NECK, TUBE, AND TIP AREAS OF THE CARTRIDGE FOR CRACKS, MELTING, ROUGHNESS, DENT, BENT TIPS OR SMASH CONDITIONS. NO CRACKING OR STRESS MARKS ARE ALLOWED. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) FOR THE CARTRIDGE WAS REVIEWED. THE DFU ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS FOR THE PROPER USE AND HANDLING OF THE CARTRIDGES. AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED COMPLAINT WAS NOT VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS INSERTED INTO THE CARTRIDGE CORRECTLY; HOWEVER, UPON INJECTION, THE CARTRIDGE CRACKED. THE CARTRIDGE MODEL WAS NOT PROVIDED. THERE WAS NO PATIENT CONTACT AND NO PATIENT CONSEQUENCE REPORTED. THROUGH FOLLOW UP IT WAS INDICATED THE LENS REMAINS IN THE CARTRIDGE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179164 PLATINUM 1 SERIES SURGICAL ADJUNCTS KYB ABBOTT MEDICAL OPTICS 1MTEC30 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1