BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 16052837 · Received December 27, 2022

    Report

    Report Number
    3012236936-2022-03196
    Event Type
    Injury
    Date Received
    December 27, 2022
    Report Date
    February 13, 2023
    Manufacturer
    JJSV MFG. MALAYSIA SDN. BHD.
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: IN REVIEWING THE INITIAL MDR: 3012236936-2022-03196, IT WAS NOTICED THAT SECTION G4 COMBINATION PRODUCT WAS INADVERTENTLY LEFT BLANK; THEREFORE, IT IS CAPTURED IN THIS SUPPLEMENTAL REPORT AND THE FIELD HAS BEEN UPDATED. SECTION G4 COMBINATION PRODUCT: NO. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D9: DEVICE AVAILABLE FOR EVALUATION? YES. SECTION D9: DATE RETURNED TO MANUFACTURER: DEC 28, 2022. SECTION H3: EVALUATED BY MANUFACTURER: YES. DEVICE EVALUATION: THE SUSPECT LENS WAS RECEIVED CUT IN HALF AND COATED IN VISCOELASTIC RESIDUE. THE LENS WAS CLEANED AND INSPECTED UNDER MAGNIFICATION AND SCRATCHES WERE OBSERVED ON THE ON THE SPARE TIRE OF THE LENS. NO ISSUES THAT COULD CAUSE OR CONTRIBUTE TO THE COMPLAINT ISSUES WERE OBSERVED. THE OTHER OBSERVED ISSUES DURING THE PRODUCT EVALUATION COULD NOT BE CONFIRMED TO BE RELATED TO A MANUFACTURING OR DESIGN ISSUE. THEREFORE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION. CONCLUSION: 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.

    Additional Manufacturer Narrative · 0

    PATIENT INFORMATION: UNKNOWN; REQUESTED BUT NOT PROVIDED. DATE OF EVENT: UNKNOWN; REQUESTED BUT NOT PROVIDED. THE BEST ESTIMATE DATE IS BETWEEN APR 8, 2021 AND NOV 28, 2022. THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE RIGHT EYE DURING A SECONDARY PROCEDURE DUE TO MECHANICAL COMPLICATIONS. THE ISSUE WAS OBSERVED DURING A POST-OPERATIVE EXAMINATION. THE PATIENT WAS UNHAPPY WITH VISUAL ACUITY (VA). ANOTHER JOHNSON AND JOHNSON IOL WAS IMPLANTED AS REPLACEMENT (DIFFERENT MODEL, DIB00, SAME DIOPTER OF 16.5). NO INCISION ENLARGEMENT, SUTURE, OR VITRECTOMY WAS REQUIRED. THERE WAS NO DELAY IN PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2586286 TECNIS IOL LENS, MULTIFOCAL INTRAOCULAR MFK JJSV MFG. MALAYSIA SDN. BHD. ZLB00

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention