BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATINUM 1 SERIES

    MDR report key: 10478607 · Received September 1, 2020

    Report

    Report Number
    2648035-2020-00658
    Event Type
    Malfunction
    Date Received
    September 1, 2020
    Date of Event
    August 3, 2020
    Report Date
    November 3, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    KYB
    UDI-DI
    05050474540323
    PMA / PMN Number
    K081545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D10. DEVICE AVAILABLE FOR EVALUATION? YES; RETURNED TO MANUFACTURER ON: 9/25/2020 SECTION H3. DEVICE RETURNED TO MANUFACTURER? YES DEVICE EVALUATION: TWO SAMPLE CONTAINERS WERE RETURNED. ONE HAD A CARTRIDGE AND THE OTHER WAS EMPTY. THE CONTAINERS WERE CAREFULLY OPENED, AND NOTHING WAS FOUND IN THE SECOND CONTAINER. CARTRIDGE TIP CRACK/DAMAGED WAS OBSERVED AND A PIECE OF THE TIP IS MISSING. THAT COULD BE RELATED TO THE HANDLING BY EXCESSIVE FORCE DURING THE INSERTION PROCESS, SINCE AS INDICATED IN THE INITIAL REPORT THE IOL HAD TO BE DISENGAGED FROM THE INJECTOR WITH THE SECOND INSTRUMENT TO FREE IT. WITH THE INFORMATION PROVIDED AND DUE TO THE CONDITIONS OF THE SAMPLE RETURNED THE REPORTED ISSUES COULD NOT BE VERIFIED. BASED IN THE ANALYSIS PRODUCT QUALITY DEFICIENCY COULD NOT BE DETERMINED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING RECORDS FOR THE DEVICE WERE REVIEWED. THERE WAS NO DEVIATION AND/OR DISCREPANCY FOUND DURING THE MRR (MANUFACTURING RECORD REVIEW). THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH IN COMPLAINT SYSTEM REVEALED THAT NO ADDITIONAL COMPLAINT WAS RECEIVED FROM THIS PRODUCTION ORDER NUMBER. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS CORRECTION MDR IS BEING SUBMITTED TO ADDRESS INACCURATE INFORMATION IN SECTION F ON THE XML VERSION OF THE PREVIOUS SUBMISSION CAUSED BY A SOFTWARE GLITCH IN THE TRANSMISSION PROCESS. THE INTERNAL NON-CONFORMANCE NUMBERS FOR THIS SOFTWARE ISSUE ARE NR-0148919 AND CAPA-010215.

    Additional Manufacturer Narrative · 1

    AGE/DATE OF BIRTH: UNKNOWN, INFORMATION NOT PROVIDED. GENDER/SEX: UNKNOWN, INFORMATION NOT PROVIDED. IF IMPLANTED; GIVE DATE: N/A (NOT APPLICABLE). THE CARTRIDGE IS NOT AN IMPLANTABLE DEVICE. IMPLANTABLE DEVICE. PHONE NUMBER: (B)(6). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANTING AN INTRAOCULAR LENS (IOL), THE TRAILING END OF THE IOL WAS A BIT TIGHT IN THE NOZZLE WITH THE PLUNGER SO THE DOCTOR HAD TO DISENGAGE THE IOL FROM THE INJECTOR WITH THE SECOND INSTRUMENT TO FREE IT. REPORTEDLY, IN THE WOUND WAS A LITTLE SHARP CURVED SHARD OF PLASTIC THAT THE DOCTOR THINKS CAME FROM THE CARTRIDGE. THE LENS WAS FULLY IMPLANTED INTO THE EYE. THE LENS REMAINS IMPLANTED IN THE EYE AND ONLY THE SHARD OF THE FOREIGN MATERIAL WAS REMOVED. IT WAS INDICATED THAT THE PATIENT IS FINE AND THE LENS IS NOT DAMAGED IN ANY WAY. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    940647 PLATINUM 1 SERIES SURGICAL ADJUNCTS KYB JOHNSON & JOHNSON SURGICAL VISION, INC. 1MTEC30 05050474540323

    Patients

    Seq Age Sex Outcome Treatment
    1 LENS, MODEL ICB00, SN: UNKNOWN