BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 20931382 · Received December 13, 2024

    Report

    Report Number
    3012236936-2024-000330
    Event Type
    Injury
    Date Received
    December 13, 2024
    Date of Event
    November 18, 2024
    Report Date
    December 19, 2024
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    MJP
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: UPON FURTHER REVIEW IT WAS NOTED THAT "G4" FIELD FOR THE PMA NUMBER WAS INADVERTENTLY POPULATED WITH P980040 ON THE INITIAL MDR; THE FIELD SHOULD HAVE BEEN LEFT BLANK. THEREFORE, THE INFORMATION IS BEING CORRECTED IN THIS SUPPLEMENTAL MDR REPORT AS PER THE FOLLOWING: SECTION G4 - PMA/510(K) #: THIS REPORT IS BEING FILED ON AN INTERNATIONAL DEVICE; TECNIS EYHANCE SIMPLICITY TORIC II OPTIBLUE WITH TECNIS SIMPLICITY, MODEL DIW SERIES THAT HAS A SIMILAR DEVICE, TECNIS EYHANCETORIC II IOL WITH TECNIS SIMPLICITY MODEL DIU WHICH IS DISTRIBUTED IN THE UNITED 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 AFTER THE PRELOADED TORIC INTRAOCULAR LENS (IOL) WAS IMPLANTED, THE CAPSULE TORE. THE PATIENT HAD A LENS IMPLANTED WITH THE ASSISTANCE OF A 2.4 MM CORNEAL WOUND. A PORTION OF THE LENS FELL FROM THE TEAR, BUT WAS REMOVED. THERE WERE NO MEDICAL INTERVENTIONS REQUIRED. THROUGH FOLLOW-UP, WE LEARNED THAT THE IOL WAS REMOVED AND A LENS FORM A DIFFERENT MANUFACTURER WAS IMPLANTED. THE PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1857442 TECNIS IOL LENS, INTRAOCULAR, TORIC OPTICS MJP AMO PUERTO RICO MFG. INC. DIW600

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention