BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMERALD

    MDR report key: 5773596 · Received July 6, 2016

    Report

    Report Number
    2648035-2016-01055
    Event Type
    Malfunction
    Date Received
    July 6, 2016
    Report Date
    October 7, 2016
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    KYB
    PMA / PMN Number
    K961242
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UDI #:UNKNOWN BECAUSE LOT/SERIAL NUMBER IS NOT AVAILABLE. DATE OF EVENT: UNKNOWN/NOT PROVIDED. BRAND NAME NOT PROVIDED. EXPIRATION DATE #: COULD NOT BE DETERMINED AS THE LOT NUMBER WAS NOT PROVIDED. IMPLANT AND EXPLANT DATES: IF IMPLANTED OR EXPLANTED, GIVE DATE: NOT APPLICABLE AS THIS IS NOT AN IMPLANTABLE DEVICE. INITIAL REPORTER PHONE NUMBER: (B)(6). PMA/510(K) COULD NOT BE DETERMINED AS NO PRODUCT INFORMATION WAS PROVIDED. DEVICE MANUFACTURING DATE: COULD NOT BE DETERMINED AS THE LOT NUMBER WAS NOT PROVIDED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO: IN REVIEWING OTHER COMPLAINT FROM THE DOCTOR REFERENCING THE SAME TYPE OF EVENT, THE REVIEW NOTED THE MODEL OF THE CARTRIDGE WAS MOST LIKELY AN EMERALD CARTRIDGE. THE MDR HAS BEEN UPDATED ACCORDINGLY. BRAND NAME: EMERALD. CATALOG #: EMERALDC30. MODEL: EMERALDC30. PMA/510(K) #: K961242. DEVICE EVALUATION: THE CARTRIDGE WAS NOT RETURNED TO THE MANUFACTURING SITE. THEREFORE, A PRODUCT INVESTIGATION WAS NOT POSSIBLE AND THE CUSTOMER'S REPORTED EVENT COULD NOT BE CONFIRMED. MANUFACTURING RECORD REVIEW: A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE PERFORMED AS THE LOT NUMBER FOR THE CARTRIDGE WAS UNKNOWN, WAS NOT PROVIDED. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) FOR THE EMERALD CARTRIDGE WAS REVIEWED. THE DFU ADEQUATELY PROVIDES INSTRUCTIONS, PRECAUTIONS, AND WARNINGS FOR THE PROPER USE AND HANDLING OF THE CARTRIDGES. FURTHER REVIEW WAS CONDUCTED FOR THE HANDPIECES THAT CAN BE USED IN CONJUNCTION WITH THE CARTRIDGE. BASED ON THE RESULTS OF THE INVESTIGATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED. THE CUSTOMER'S REPORTED COMPLAINT COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    A PHYSICIAN NOTICED A CARTRIDGE HAVING A BENT BEVEL. THE PHYSICIAN NOTED SIMILAR ISSUES IN THE PAST. THIS REPORT WILL CAPTURE THE NOTED PAST OCCURRENCE. A SEPARATE MDR WAS FILED TO CAPTURE THE CURRENT BENT BEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426340 EMERALD SURGICAL ADJUNCTS KYB ABBOTT MEDICAL OPTICS EMERALDC30 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1