BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 8697706 · Received June 13, 2019

    Report

    Report Number
    3011852734-2019-00125
    Event Type
    Injury
    Date Received
    June 13, 2019
    Report Date
    November 12, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    MFK
    UDI-DI
    05050474560062
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE AVAILABLE FOR EVALUATION: YES. RETURNED TO MANUFACTURER ON: 6/04/2019. DEVICE RETURNED TO MANUFACTURER: YES. DEVICE EVALUATION: THE LENS WAS RECEIVED IN A PLASTIC SAMPLE JAR WITH A STICKER NOTING PATIENT AND PROCEDURE INFORMATION. A VISUAL INSPECTION OF THE LENS SHOWS DAMAGE TO THE CENTER OF THE OPTIC. THE LENS WAS CLEANED WITH PURIFIED WATER AND DRIED WITH COMPRESSED AIR TO EASE INSPECTION. FURTHER INSPECTION UNDER MAGNIFICATION SHOWS DAMAGE ON BOTH SIDES OF THE OPTIC, PROBABLY DUE TO HANDLING DURING EXPLANT. SINCE THE LENS WAS PREPARED AND SURGICALLY INSERTED TO THE PATIENTS EYE IT COULD NOT BE DETERMINED THAT THE DAMAGED ON THE DEVICE IS RELATED TO THE MANUFACTURING PROCESS. THE COMPLAINT ISSUE REPORTED COULD NOT BE VERIFIED AND NO PRODUCT DEFICIENCY COULD BE IDENTIFIED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. HISTORICAL DATA ANALYSIS: A SEARCH OF COMPLAINTS REVEALED NO OTHER COMPLAINTS HAVE BEEN RECEIVED FOR THIS PRODUCTION ORDER NUMBER. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A QUALITY PRODUCT DEFICIENCY AND THE REPORTED ISSUE COULD NOT BE VERIFIED. 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

    DATE OF EVENT: EXACT DATE NOT PROVIDED, BEST ESTIMATE DATE IS BETWEEN 3/13/2018 - 1/16/2019 (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE DUE TO PATIENT COMPLAINT OF HAZING OR GLARE AND HALOS. THE LENS WAS REPLACED WITH A NON J&J LENS. PATIENT WAS REPORTED AS HAPPY AND DOING WELL POST OP. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490510 TECNIS 1 MULTIFOCAL MULTIFOCAL IOLS MFK JOHNSON & JOHNSON SURGICAL VISION, INC. ZKB00 05050474560062

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention