BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 8681031 · Received June 7, 2019

    Report

    Report Number
    3011852734-2019-00121
    Event Type
    Injury
    Date Received
    June 7, 2019
    Date of Event
    May 6, 2019
    Report Date
    November 12, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    MFK
    UDI-DI
    05050474560635
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    ADDITIONAL INFORMATION RECEIVED REVEALED THE PATIENT REPORTED ON (B)(6) 2019 HAVING BLURRY VISION. THE DOCTOR THAT THE INTRAOCULAR LENS (IOL) HAD DECENTERED SLIGHTLY. THERE WERE NO INJURIES DURING THE EXPLANT AND THE PATIENT IS DOING FINE. AS A RESULT THE FOLLOWING FIELDS HAVE BEEN UPDATED: ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN, NOT PROVIDED. (B)(4). DEVICE EVALUATION: THE INTRAOCULAR LENS (IOL) WAS RETURNED TO THE MANUFACTURING SITE FOR EVALUATION. VISUAL INSPECTION FOUND RESIDUE OF LUBRICANT MATERIAL ON THE LENS. THE LENS WAS OBSERVED TO BE IN GOOD CONDITION. THE CONDITION OF THE LENS RETURNED IS CONSISTENT WITH A UNIT THAT HAS BEEN PREVIOUSLY USED IN A SURGICAL PROCESS. THE COMPLAINT ISSUE REPORTED COULD NOT BE VERIFIED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WAS REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH ON COMPLAINTS REVEALED THAT NO OTHER COMPLAINTS HAVE BEEN RECEIVED FOR THIS PRODUCTION ORDER NUMBER. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WAS REVIEWED. THE DFU ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS ALONG WITH WARNINGS FOR THE PROPER USE AND HANDLING OF THE DEVICE. AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A ZLB00 INTRAOCULAR LENS (IOL) WAS REMOVED AND EXCHANGED FROM THE LEFT EYE. THE IOL HAD DECENTERED, AND WAS EXCHANGED FOR A SULCUS ZMA00 IOL. THERE WAS NO INTERVENTION REQUIRED AND THE PATIENT WAS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471924 TECNIS 1 MULTIFOCAL MULTIFOCAL IOLS MFK JOHNSON & JOHNSON SURGICAL VISION, INC. ZLB00 05050474560635

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention