BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 16056722 · Received December 27, 2022

    Report

    Report Number
    3012236936-2022-03214
    Event Type
    Malfunction
    Date Received
    December 27, 2022
    Report Date
    January 30, 2023
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IF IMPLANTED; GIVE DATE: UNKNOWN/NOT PROVIDED. THE LENS REMAINS IMPLANTED. IF EXPLANTED; GIVE DATE: N/A (NOT APPLICABLE). THE LENS REMAINS IMPLANTED. TELEPHONE NUMBER: (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL DEVICE; TECNIS OPTIBLUE SIMPLICITY PRELOADED 1-PIECE IOL, MODEL DIB00V THAT HAS A SIMILAR DEVICE, TECNIS SIMPLICITY PRELOADED 1-PIECE IOL MODEL DIB00 WHICH IS DISTRIBUTED IN THE UNITES STATES UNDER PMA P980040. THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT REMAINS IMPLANTED; 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. ATTEMPTS WERE MADE TO OBTAIN THE MISSING INFORMATION; HOWEVER, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D9: DEVICE AVAILABLE FOR EVALUATION? YES. SECTION D9: RETURNED TO MANUFACTURER ON: 12/16/2022. SECTION H3: DEVICE EVALUATED BY MANUFACTURER¿ YES. DEVICE EVALUATION: NO COMPLAINT LENS WAS RECEIVED WITH THE RETURNED PRODUCT AND THEREFORE NO EVALUATION ON THE LENS COULD BE PERFORMED. NO DEFECTS OR ASSEMBLY ISSUES WERE OBSERVED WITH THE HANDPIECE BEFORE AND AFTER DISASSEMBLY. THE MANUFACTURING RECORDS REVIEW FOR THE PRODUCT SHOWED THE UNIT WAS RELEASED WITHIN SPECIFICATION. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TRAILING HAPTIC OF THE INTRAOCULAR LENS (IOL) BECAME STUCK BETWEEN THE PLUNGER AND THE TIP OF THE CARTRIDGE DURING IMPLANTATION. THE IOL WAS PULED OUT WITH TWEEZERS IN ORDER TO BE IMPLANTED INTO THE EYE. THERE WAS NO REPORTED PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2139602 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00V

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown