BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 21990180 · Received May 8, 2025

    Report

    Report Number
    3012236936-2025-000132
    Event Type
    Malfunction
    Date Received
    May 8, 2025
    Date of Event
    April 12, 2025
    Report Date
    May 8, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474655423
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D6A: IF IMPLANTED, GIVE DATE: NOT APPLICABLE AS THE LENS ARE NOT IMPLANTED. SECTION D6B: IF EXPLANTED, GIVE DATE: NOT APPLICABLE AS THE LENS ARE NOT IMPLANTED. SECTION E1: EMAIL ADDRESS, ADDRESS, TELEPHONE NUMBER: UNKNOWN, INFORMATION NOT PROVIDED. DEVICE EVALUATION: THE PRODUCT WAS NOT RETURNED FOR EVALUATION; THEREFORE, TESTING OF THE DEVICE WAS NOT POSSIBLE. MANUFACTURING RECORD EVALUATION: BASED ON THE MANUFACTURING RECORDS REVIEW, AND HISTORICAL COMPLAINT REVIEW, THERE IS NO INDICATION OF A PRODUCT MALFUNCTION OR PRODUCT QUALITY DEFICIENCY. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ATTEMPTS HAVE BEEN MADE TO OBTAIN 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 HAPTIC WAS SCRATCH. THERE WAS NO PATIENT CONTACT. IOL WAS NOT USED. IOL IS NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    997259 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00 05050474655423

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown