BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 14691651 · Received June 15, 2022

    Report

    Report Number
    3012236936-2022-01557
    Event Type
    Malfunction
    Date Received
    June 15, 2022
    Date of Event
    May 20, 2022
    Report Date
    August 24, 2022
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474636613
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: UPON FURTHER REVIEW IT WAS OBSERVED THAT SECTION "G2" SHOULD HAVE INCLUDED "COMPANY REPRESENTATIVE" WHICH INADVERTENTLY WAS NOT SELECTED IN THE INITIAL MDR REPORT. IT WAS ALSO NOTED THAT THE SECTION "G4" OF THE INITIAL MDR REPORT WAS INADVERTENTLY POPULATED WITH THE PMA# P980040 WHICH IS INCORRECT. THE "G4" FIELD SHOULD HAVE BEEN KEPT EMPTY AND THE JUSTIFICATION FOR THAT SHOULD HAVE BEEN CAPTURED TO THE SECTION "H10" OF THE INITIAL MDR REPORT AND THAT THE CODE "4114" WAS INADVERTENTLY USED INSTEAD OF "4117" IN THE INITIAL MDR REPORT, WHICH THEY ALL HAVE BEEN CORRECTED IN THIS SUPPLEMENTAL MDR REPORT. THE FOLLOWING FIELDS WERE UPDATED ACCORDINGLY: SECTION G2 - REPORT SOURCE ADDED: COMPANY REPRESENTATIVE. SECTION H6: TYPE OF INVESTIGATION: 4117. SECTION G4: THIS REPORT IS BEING FILED ON AN INTERNATIONAL DEVICE; TECNIS OPTIBLUE SIMPLICITY PRELOADED 1-PIECE IOL, MODEL DCB00V THAT HAS A SIMILAR DEVICE, TECNIS SIMPLICITY PRELOADED 1-PIECE IOL MODEL DCB00 WHICH IS DISTRIBUTED IN THE UNITES STATES UNDER PMA P980040. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    AGE OR DATE OF BIRTH AND WEIGHT : UNKNOWN, INFORMATION NOT PROVIDED. EXPLANT DATE: IF EXPLANTED, GIVE DATE: NOT APPLICABLE, LENS REMAINS IMPLANTED IN THE EYE. EMAIL ADDRESS: (B)(6). TELEPHONE NUMBER: (B)(6). 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 HAVE BEEN MADE TO OBTAIN THE MISSING INFORMATION; HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING IMPLANTATION, A PRELOADED INTRAOCULAR LENS (IOL) CAME OUT IN THE PATIENT¿S OPERATIVE EYE WITH ITS TRAILING HAPTIC STUCK BETWEEN THE PLUNGER ROD AND THE INNER CARTRIDGE. THE DOCTOR MANAGED THE HAPTIC TO BE PULLED OUT, AND THE TIP OF THE TRAILING HAPTIC WAS FOUND TO BE DETACHED. THE IOL WAS AFFIXED AT THE CENTER OF THE EYE AFTER IMPLANTATION. THE LENS REMAINS IMPLANTED AND THE PATIENT IS BEING MONITORED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2836927 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DCB00V 05050474636613

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown