BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 15553469 · Received October 6, 2022

    Report

    Report Number
    3012236936-2022-02548
    Event Type
    Malfunction
    Date Received
    October 6, 2022
    Date of Event
    September 6, 2022
    Report Date
    October 21, 2022
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474739321
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION H3: DEVICE EVALUATED BY MANUFACTURER: YES . DEVICE EVALUATION: THE COMPLAINT LENS WAS RECEIVED LOOSE IN A PLASTIC BAG. THE COMPLAINT HANDPIECE WAS RECEIVED AS WELL. VISUAL INSPECTION UNDER MAGNIFICATION REVEALED LENS DAMAGE ON THE LENS OPTIC AFTER CLEANING THE LENS. CARTRIDGE TIP DAMAGE AND PLUNGER ROD TIP DAMAGE WAS OBSERVED PRIOR TO HANDPIECE DISASSEMBLY. THE HANDPIECE WAS DISASSEMBLED AND NO FURTHER DEFECTS WERE OBSERVED. THE COMPLAINT ISSUE (HAPTIC DAMAGED) WAS NOT CONFIRMED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING RECORDS FOR THE INTRAOCULAR LENS WERE REVIEWED AND NO NON-CONFORMANCE REPORT (NC) WAS FOUND AS PART OF THIS MANUFACTURING RECORDS REVIEW. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. THE SEARCH REVEALED THAT NO OTHER COMPLAINTS FOR THIS PRODUCTION ORDER NUMBER HAVE BEEN RECEIVED. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    IF IMPLANTED/EXPLANTED GIVE DATE: NOT APPLICABLE, NO PATIENT CONTACT WITH THE PRODUCT. INITIAL REPORTER TELEPHONE NUMBER: (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL DEVICE; TECNIS EYHANCE OPTIBLUE SIMPLICITY, MODEL DIB00V THAT HAS A SIMILAR DEVICE, TECNIS SIMPLICITY TECNIS EYHANCE IOL MODEL DIB00 WHICH IS DISTRIBUTED IN THE UNITES STATES UNDER PMA P980040. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A TIP OF THE LEAD HAPTIC OF AN INTRAOCULAR LENS (IOL) HAD REVERSELY COME OUT IN A V-SHAPE DURING THE SETTING OF THE IOL, THAT IT WAS DEFORMED. IT GOT STUCK WHEN THE TIP OF ITS CARTRIDGE HAD BEEN PUSHED OUT. THERE WAS NO RESISTANCE FEELING WHEN ITS PLUNGER HAD BEEN PUSHED OUT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE BACK-UP. THERE WAS NO PATIENT CONTACT AS THE ISSUE WAS PRIOR TO USE. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2800122 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00V 05050474739321

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown