BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATINUM 1 SERIES

    MDR report key: 7455063 · Received April 24, 2018

    Report

    Report Number
    3011852734-2018-00060
    Event Type
    Malfunction
    Date Received
    April 24, 2018
    Date of Event
    March 26, 2018
    Report Date
    July 2, 2018
    Manufacturer
    JOHNSON AND JOHNSON SURGICAL VISION, INC.
    Product Code
    KYB
    UDI-DI
    05050474531642
    PMA / PMN Number
    K081545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS DISCOVERED THAT THE EVENT OF PARTIALLY DELIVERS WAS REPORTED AGAINST THE LENS. FOR A COMPLAINT OF PARTIALLY DELIVERS AND STUCK IN CARTRIDGE, THE REPORT SHOULD BE AGAINST THE CARTRIDGE WITH THE LENS AS A CONCOMITANT PRODUCT. A CORRECTION MDR IS REQUIRED. THE FOLLOWING FIELDS HAVE BEEN UPDATED: BRAND NAME: PLATINUM 1 SERIES. PRODUCT CODE#: KYB. COMMON DEVICE NAME: SURGICAL ADJUNCTS. MODEL#: 1MTEC30. CATALOG#: 1MTEC30. LOT#: CD00737. EXPIRATION DATE: 1/18/2019 UDI #: (B)(4). CONCOMITANT MEDICAL PRODUCTS: ZCB00, SERIAL #: (B)(4). MANUFACTURING SITE ADDRESS: ROAD 402 NORTH, KM 4.2, ANASCO INDUSTRIAL PARK, POB 14, ANASCO, PR, US. 00610. PMA/510(K) #: K081545. DEVICE MANUFACTURE DATE: 1/18/2018. DEVICE EVALUATION: SINCE PRODUCT IS NOT AVAILABLE, THE REPORTED COMPLAINT ISSUE COULD NOT BE VERIFIED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATIONS. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WERE REVIEWED. THE DFU PROVIDE THE CUSTOMER WITH PROPER USAGE INSTRUCTIONS AND GUIDELINES. CONCLUSION: 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: N/A (NOT APPLICABLE). THE INTRAOCULAR LENS WAS NOT IMPLANTED. IF EXPLANTED; GIVE DATE: N/A (NOT APPLICABLE). THE INTRAOCULAR LENS WAS NOT IMPLANTED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LENS WOULD NOT FULLY COME OUT OF THE CARTRIDGE AND WAS PARTIALLY DELIVERED INTO THE LEFT EYE DUE TO POSSIBLE LOADING ERROR. ANOTHER LENS WAS USED. THERE WAS NO NEED FOR INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES. THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON AND JOHNSON SURGICAL VISION, INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296820 PLATINUM 1 SERIES SURGICAL ADJUNCTS KYB JOHNSON AND JOHNSON SURGICAL VISION, INC. 1MTEC30 CD00737 05050474531642

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR ZCB00, SERIAL #: (B)(4)