BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 20364212 · Received October 3, 2024

    Report

    Report Number
    3012236936-2024-000269
    Event Type
    Malfunction
    Date Received
    October 3, 2024
    Date of Event
    September 27, 2024
    Report Date
    November 3, 2024
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474636040
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UY
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE CUSTOMER PROVIDED PHOTOS WHICH WERE EVALUATED. THE PHOTOS DISPLAY THE SUSPECT PRODUCT CARTRIDGE AND THE PLUNGER ROD CAN BE OBSERVED TO BE FULLY ADVANCED. THE CARTRIDGE TIP CAN BE OBSERVED TO BE DEFORMED. DUE TO NO PRODUCT RECEIVED, NO FURTHER EVALUATION COULD BE PERFORMED, AND NO FURTHER ISSUES COULD BE IDENTIFIED. BASED ON THE COMPLAINT INVESTIGATION RESULTS, THE PRODUCT WAS RELEASED WITHIN SPECIFICATIONS. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY, AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION A6, PATIENT INFORMATION: UNKNOWN/NOT PROVIDED. SECTION D6B, IF EXPLANTED, GIVE DATE: NOT APPLICABLE AS THE IOL REMAINS IMPLANTED. SECTION E1, TELEPHONE NUMBER: (B)(6). ENTERING THE TELEPHONE NUMBER IN H11 AS THE FIELD ONLY TAKES THE US FORMAT. SECTION H3, DEVICE EVALUATED BY MANUFACTURER: THE DEVICE HAS NOT BEEN 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 WILL BE FILED. ATTEMPTS HAVE BEEN MADE TO OBTAIN THE MISSING INFORMATION. HOWEVER, TO DATE, IT HAS NOT 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 THE INJECTOR ON THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS DEFECTIVE. THE IOL WAS DEPLOYED IN A MORE VIOLENT MANNER THAN USUAL AND THAT IN THE PERIPHERAL PART IT LOOKED LIKE ¿SPLINTERS.¿ THE DOCTOR STATES THAT THE INJECTOR WAS NOT PERFECTLY SMOOTH AND THAT WHEN INSERTING THE LENS, HE OBSERVED A KIND OF SPLINTER IN ITS PERIPHERAL AREA. HE ALSO REPORTS THAT THE LENS DEPLOYED VIOLENTLY. THE CUSTOMER EXAMINED THE INJECTOR AND NOTED SOME IRREGULARITY AT THE TIP. THE LENS WAS PLACED IN THE PATIENT AND REMAINS IMPLANTED. WHEN THE DOCTOR SEES THE PATIENT, HE HOPES NOT TO HAVE ANY PROBLEMS SINCE THE DEFECT IS NOT IN THE OPTICS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1443685 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DCB00 05050474636040

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown