BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 16757136 · Received April 17, 2023

    Report

    Report Number
    3012236936-2023-00896
    Event Type
    Injury
    Date Received
    April 17, 2023
    Date of Event
    March 23, 2023
    Report Date
    June 7, 2023
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    UDI-DI
    05050474652668
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A4 AND A5: UNKNOWN/ NOT PROVIDED. PATIENT INFORMATION CANNOT BE PROVIDED DUE TO PERSONAL DATA PRIVACY LEGISLATION/POLICY. SECTION E1: EMAIL ADDRESS: UNKNOWN/NOT PROVIDED, AS INFORMATION WAS ASKED BUT IT WAS NOT PROVIDED. SECTION E1: TELEPHONE NUMBER: (B)(6). SECTION H3-OTHER (81):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. 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. DATE RETURNED TO MANUFACTURER: 19 APRIL 2023. SECTION H3: DEVICE EVALUATED BY MANUFACTURER: YES. DEVICE EVALUATION: THE SUSPECT INTRAOCULAR LENS (IOL) WAS RECEIVED CUT IN SEVERAL PIECES. THE IOL WAS CLEANED AND VISUAL INSPECTION UNDER MAGNIFICATION FOUND NO ISSUES THAT COULD CAUSE OR CONTRIBUTE TO THE COMPLAINT EVENT. NO FURTHER EVALUATION WAS PERFORMED. THE COMPLAINT ISSUE BLURRY, HALOS, GLARES AND EXPLANT WERE NOT IDENTIFIED DURING PRODUCT EVALUATION. THE OTHER OBSERVED ISSUES DURING THE PRODUCT EVALUATION COULD NOT BE CONFIRMED TO BE RELATED TO THE MANUFACTURING OR DESIGN PROCESS. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER IMPLANTATION OF THE INTRAOCULAR LENS (IOL) THE PATIENT EXPERIENCED UNCLEAR (WAXY) VISION AND DISCOMFORT DURING NIGHT TIME DUE TO GLARE AND HALO. THE IOL WAS EXPLANTED AND REPLACED WITH A ZEISS TRIFOCAL IOL. VISION PRE-OPERATIVE: 0.6 AND VISION POST-OPERATIVE:0.6. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2320140 TECNIS IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS ZFR00V 05050474652668

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention