BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMERALD

    MDR report key: 7501809 · Received May 10, 2018

    Report

    Report Number
    2648035-2018-00684
    Event Type
    Malfunction
    Date Received
    May 10, 2018
    Date of Event
    April 10, 2018
    Report Date
    October 16, 2018
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    KYB
    UDI-DI
    05050474530027
    PMA / PMN Number
    K961242
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE AVAILABLE FOR EVALUATION? YES. RETURNED TO MANUFACTURER ON: 08/25/2018. DEVICE RETURNED TO MANUFACTURER? YES. DEVICE EVALUATION: THE CARTRIDGE WAS RETURNED AT THE MANUFACTURING SITE FOR EVALUATION. VISUAL INSPECTION UNDER THE MICROSCOPE SHOWED THAT THE CARTRIDGE HAD THE TIP DEFORMED. THE INTRAOCULAR LENS (IOL) WAS OBSERVED STUCK AT THE CARTRIDGE TUBE. EVIDENCE OF VISCOELASTIC RESIDUE WAS OBSERVED IN THE CARTRIDGE WINGS AND LOADING ZONE. BASED ON THE EVIDENCE OBSERVED THE CARTRIDGE WAS HANDLED AND USED. THE CUSTOMER'S REPORTED COMPLAINT WAS VERIFIED. HOWEVER, THERE IS NO EVIDENCE TO SUGGEST THAT THE COMPLAINT SAMPLE HAS BEEN AFFECTED BY THE MANUFACTURING PROCESS. NO PRODUCT DEFICIENCY WAS IDENTIFIED. MANUFACTURING RECORDS REVIEW: THE LOT NUMBER IS UNKNOWN; THEREFORE THE MANUFACTURING RECORDS COULD NOT BE REVIEWED. 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 AND THE REPORTED ISSUE COULD NOT BE VERIFIED. 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). DEVICE MANUFACTURE DATE: UNKNOWN, AS THE LOT NUMBER OF THE DEVICE WAS NOT PROVIDED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CARTRIDGE TIP HAD A BUMP ON IT. REPORTEDLY, THE ISSUE WAS NOTICED PRIOR TO IMPLANTATION AND THE INTRAOCULAR LENS (IOL) ZA9003 IS STILL INSIDE THE DELIVERY SYSTEM. THERE WAS NO PATIENT INJURY OR INVOLVEMENT REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345814 EMERALD SURGICAL ADJUNCTS KYB JOHNSON & JOHNSON SURGICAL VISION, INC. EMERALDC30 UNKNOWN 05050474530027

    Patients

    Seq Age Sex Outcome Treatment
    1 ZA9003 LENS, SERIAL NUMBER (B)(4)| ZA9003 LENS, SERIAL NUMBER (B)(4)