BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 20799373 · Received November 27, 2024

    Report

    Report Number
    3012236936-2024-000305
    Event Type
    Malfunction
    Date Received
    November 27, 2024
    Date of Event
    October 25, 2024
    Report Date
    November 27, 2024
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474739451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D6B - EXPLANT DATE: NOT APPLICABLE, AS LENS REMAINS IMPLANTED. SECTION E1 - TELEPHONE NUMBER: (B)(6). SECTION G4: PMA/510(K) NUMBER: 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. SECTION H3: THE INTRAOCULAR LENS (IOL) WAS NOT RETURNED FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT 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 AND POSSIBLE PRODUCT RETURN AND EVALUATION, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. AN ATTEMPT HAS BEEN MADE TO OBTAIN THE MISSING INFORMATION. HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. 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 PHYSICIAN NOTICED A CRACK IN THE PRELOADED INTRAOCULAR LENS (IOL) AFTER SURGERY. THE PATIENT EXPERIENCED NO ISSUES, AND THE VISUAL FUNCTION WAS NOT AFFECTED. NO PATIENT INJURY REPORTED. NO MEDICAL INTERVENTION WAS REQUIRED. THROUGH FOLLOW-UP, WE LEARNED THAT THE TYPE OF VISCOELASTIC USED DURING THE PROCEDURE WAS UNKNOWN; HOWEVER, IT WAS NOT A COMBINATION OF BALANCED SALT SOLUTION (BSS) AND OPHTHALMIC VISCOSURGICAL DEVICE (OVD). THE VISCOELASTIC WAS INTRODUCED FROM THE CARTRIDGE CANOPY. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850962 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00V 05050474739451

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown