BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 19356050 · Received May 20, 2024

    Report

    Report Number
    3012236936-2024-000144
    Event Type
    Injury
    Date Received
    May 20, 2024
    Report Date
    June 12, 2024
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    UDI-DI
    05050474560130
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION B-3: DATE OF EVENT: UNKNOWN/ASKED INFORMATION UNAVAILABLE. THE BEST ESTIMATION DATE IS BETWEEN (B)(6) 2024 (IOL IMPLANT AND EXPLANT DATES). 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 REPORT WILL BE FILED. SECTION H-6 MEDICAL DEVICE PROBLEM CODE: 1069 ALTHOUGH LENS MALFUNCTION WAS REPORTED, IT IS UNKNOWN WHAT THE REPORTED ISSUE IS FOR LENS MALFUNCTION IN REFERENCE TO THE EXPLANTED INTRAOCULAR LENS (IOL). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D-9: DEVICE AVAILABLE FOR EVALUATION: YES. SECTION D-9: DEVICE DATE RETURNED TO MANUFACTURER: 28-MAY-2024. SECTION H-3: DEVICE EVALUATED BY MANUFACTURER: YES. DEVICE EVALUATION: HALF OF THE LENS WAS RECEIVED IN A GAUZE. THE LENS WAS INSPECTED UNDER MAGNIFICATION. THE COMPLAINT LENS WAS RECEIVED CUT IN HALF WITH ONE HALF MISSING. THE LENS PRESENTED WITH DAMAGE AND A SPECTRUM ON THE HAPTIC THAT WAS WITHIN SPECIFICATION. BASED ON THE COMPLAINT INVESTIGATION RESULTS, THE COMPLAINT ISSUE COULD NOT BE CONFIRMED TO BE RELATED TO THE MANUFACTURING OR DESIGN PROCESS. THEREFORE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION. CONCLUSION: BASED ON THE COMPLAINT INVESTIGATION RESULTS, THE PRODUCT WAS RELEASED WITHIN SPECIFICATIONS. NO PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION WAS IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE ZKB00 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). DUE TO COMPLAINTS OF LENS MALFUNCTION, THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A NON-J&J IOL. THERE WAS NO INCISION ENLARGEMENT, NO SERIOUS PATIENT INJURY, NO SUTURE(S), AND NO VITRECTOMY DURING THE LENS EXCHANGE PROCEDURE. PATIENT STATUS POST-LENS EXCHANGE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1155972 TECNIS IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS ZKB00 05050474560130

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention