BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS IOL

    MDR report key: 11823449 · Received May 13, 2021

    Report

    Report Number
    2648035-2021-07802
    Event Type
    Malfunction
    Date Received
    May 13, 2021
    Report Date
    May 13, 2021
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE OR DATE OF BIRTH, WEIGHT, AND ETHNICITY: INFORMATION UNKNOWN/NOT PROVIDED. DATE OF EVENT: UNKNOWN, NOT PROVIDED. SERIAL NUMBER: UNKNOWN, INFORMATION NOT PROVIDED. A COMPLETE CATALOG NUMBER IS UNKNOWN AS THE SERIAL NUMBER WAS NOT PROVIDED. EXPIRATION DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. UDI NUMBER: A COMPLETE UDI NUMBER IS UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. IF IMPLANTED, GIVE DATE: INFORMATION UNKNOWN/NOT PROVIDED. IF EXPLANTED, GIVE DATE: NOT APPLICABLE AS THERE IS NO INDICATION THAT THE LENS WAS EXPLANTED. REPORTER EMAIL ADDRESS: UNKNOWN/NOT PROVIDED. REPORTER PHONE NUMBER: (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL DEVICE; TECNIS OPTIBLUE 1-PIECE IOL, THAT HAS A SIMILAR DEVICE, TECNIS 1-PIECE IOL MODEL ZCB00 WHICH IS DISTRIBUTED IN THE UNITED STATES UNDER PMA P980040. DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. DEVICE EVALUATION: THE PRODUCT TESTING COULD NOT BE PERFORMED AS THE PRODUCT WAS NOT RETURNED (THE LENS REMAINS IMPLANTED). THE REPORTED COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORD EVALUATION: MANUFACTURING RECORD REVIEW CANNOT BE PERFORMED SINCE THE SERIAL NUMBER IS UNKNOWN. A HISTORICAL REVIEW CANNOT BE PERFORMED SINCE THE SERIAL NUMBER IS UNKNOWN. CONCLUSION: NO SAMPLE WAS RETURNED, AND THE SERIAL NUMBER IS UNKNOWN AN INVESTIGATION COULD NOT BE PERFORMED, AND NO MALFUNCTION IS CONFIRMED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PREOPERATIVE CORNEAL ASTIGMATISM WAS ZERO DIOPTER (0D), BUT THE ASTIGMATISM POWER INCREASED AFTER IMPLANTING AN INTRAOCULAR LENS. THE REPORTED PHYSICIAN COMMENTED THAT THE PRODUCT SURFACE TREATMENT, THE SURFACE INCLUDING THE CONDITION OF THE LACE CUT DURING IOL MANUFACTURING SEEMS TO BE DIFFERENT FROM PREVIOUS ONES. NO POST-OP ASTIGMATISM EVALUATION WAS PROVIDED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716529 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. ZCB00V

    Patients

    Seq Age Sex Outcome Treatment
    1