BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATINUM 1 SERIES

    MDR report key: 7568157 · Received June 5, 2018

    Report

    Report Number
    2648035-2018-00830
    Event Type
    Malfunction
    Date Received
    June 5, 2018
    Date of Event
    May 7, 2018
    Report Date
    July 19, 2018
    Manufacturer
    JOHNSON AND JOHNSON SURGICAL VISION, INC.
    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: 06/06/2018. DEVICE RETURNED TO MANUFACTURER? YES. DEVICE EVALUATION: THE CARTRIDGE WAS RETURNED AT THE MANUFACTURING SITE FOR EVALUATION. VISUAL INSPECTION AT 10X MICROSCOPE MAGNIFICATION SHOWED TRACES OF VISCOELASTIC AT THE CARTRIDGE TIP. THE CARTRIDGE WAS OBSERVED DEFORMED/CRACKED (SPLIT). THE VISUAL INSPECTION DOES NOT REVEAL A MOLDING DEFECT. THE CONDITIONS OF THE RETURNED SAMPLE SUGGESTED THAT THE CARTRIDGE TIP COULD HAVE BEEN BROKEN WITH THE HANDPIECE PUSH ROD. THE CUSTOMER'S REPORTED COMPLAINT FOR CARTRIDGE BROKEN WAS VERIFIED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE CARTRIDGE WERE REVIEWED. DURING MANUFACTURING THE OPERATORS INSPECT 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. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH REVEALED THAT NO ADDITIONAL INVESTIGATION REQUESTS 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 JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    IF IMPLANTED, GIVE DATE: NOT APPLICABLE AS THIS IS NOT AN IMPLANTABLE DEVICE. IF EXPLANTED, GIVE DATE: NOT APPLICABLE AS THIS IS NOT AN IMPLANTABLE DEVICE. (B)(6). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL), OR WHILE PULLING THE INJECTOR OUT OF THE PATIENT'S EYE, A SMALL PIECE OF PLASTIC BROKE OFF THE CARTRIDGE. REPORTEDLY, THE PLASTIC PIECE WAS REMOVED WITHOUT INJURY. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411786 PLATINUM 1 SERIES SURGICAL ADJUNCTS KYB JOHNSON AND JOHNSON SURGICAL VISION, INC. 1MTEC30 CD02750 05050474540323

    Patients

    Seq Age Sex Outcome Treatment
    1 IOL, MODEL AND SERIAL NUMBER UNKNOWN