BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATINUM 1 SERIES

    MDR report key: 9537292 · Received January 2, 2020

    Report

    Report Number
    2648035-2020-00004
    Event Type
    Malfunction
    Date Received
    January 2, 2020
    Date of Event
    December 5, 2019
    Report Date
    November 4, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    KYB
    UDI-DI
    05050474540323
    PMA / PMN Number
    K961242
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 · 0

    SECTION D10. DEVICE AVAILABLE FOR EVALUATION? YES; RETURNED TO MANUFACTURER ON: 01/23/2020 SECTION H3. DEVICE RETURNED TO MANUFACTURER? YES. DEVICE EVALUATION: THE SAMPLE WAS RECEIVED AT THE MANUFACTURING SITE FOR EVALUATION. VISUAL INSPECTION WITH NO MAGNIFICATION HELD AT 18¿ DISTANCE, AND THEN USING MAGNIFICATION WAS PERFORMED. RESIDUES OF VISCOELASTIC WAS OBSERVED AT THE CARTRIDGE TUBE AND TIP. THE CARTRIDGE TIP WAS OBSERVED DAMAGED/CRACKED¿. THE CONDITION OF THE CARTRIDGE RETURNED IS CONSISTENT WITH A UNIT THAT HAS BEEN DAMAGED BY THE CONTACT OF THE METAL ROD TIP FROM THE HAND PIECE TOOL DURING SURGICAL USE. NO FOREIGN MATERIAL SUCH AS ¿PIECE OF PLASTIC LOOSE¿ WAS FOUND DURING SAMPLE EVALUATION. THE FOREIGN MATERIAL IN QUESTION WAS NOT OBSERVED ON THE RETURN. ALSO, THE INSIDE OF THE CARTRIDGE WAS OBSERVED FREE OF FOREIGN CONTAMINATION. THE REPORTED ISSUE COULD NOT BE VERIFIED. NO PRODUCT DEFICIENCY WAS IDENTIFIED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE DEVICE WERE REVIEWED. NO DEVIATION SUCH AS NON-CONFORMANCE (NC/NCR) WAS FOUND DURING PROCESS RELATED TO THE COMPLAINT ISSUE REPORTED. UNITS WERE PROCESSED AND RELEASED ACCORDING TO ESTABLISHED PROCEDURES. THE SEARCH IN THE COMPLAINT SYSTEM REVEALED NO ADDITIONAL INVESTIGATION REQUESTS (IR) WERE RECEIVED FOR THIS LOT 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. H3 OTHER TEXT: PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    NOT APPLICABLE AS THIS IS NOT AN IMPLANTABLE DEVICE. NOT APPLICABLE AS THIS IS NOT AN IMPLANTABLE DEVICE. (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 WHEN IMPLANTING AN INTRAOCULAR LENS INTO THE PATIENTS LEFT EYE, A PIECE OF PLASTIC WAS ON THE TIP OF THE INJECTOR. THE LENS WENT INTO THE EYE WITHOUT INCIDENT. ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT THE PIECE OF PLASTIC MADE CONTACT WITH THE EYE. THE WAS NO INTERVENTION REQUIRED. NO ADDITIONAL INFORMATION WAS RECEIVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR ZCB00 LENS SN: (B)(6).