BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 16401120 · Received February 17, 2023

    Report

    Report Number
    3012236936-2023-00331
    Event Type
    Injury
    Date Received
    February 17, 2023
    Date of Event
    January 12, 2023
    Report Date
    February 17, 2023
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    MJP
    UDI-DI
    05050474747753
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: RACE: UNKNOWN. DEVICE EVALUATION: PRODUCT TESTING COULD NOT BE PERFORMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION. THEREFORE, THE REPORTED ISSUE COULD NOT BE VERIFIED, AND PRODUCT QUALITY DEFICIENCY COULD NOT BE DETERMINED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH OF COMPLAINTS RELATED TO THIS PRODUCTION ORDER (PO) WAS PERFORMED. THE SEARCH REVEALED THAT NO ADDITIONAL COMPLAINTS WERE RECEIVED FOR THIS PO. NO ESCALATION REQUIRED. CONCLUSION: A PRODUCT DEFICIENCY HAS NOT BEEN IDENTIFIED; THEREFORE, NO ADDITIONAL CORRECTIVE ACTIONS HAVE BEEN INITIATED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT'S OCULAR DEXTER (RIGHT EYE). THE IOL WAS REMOVED AND REPLACED DUE TO COMPLAINTS OF HEALED HYPEROPIC, REFRACTIVE SURPRISE. THERE WAS NO DELAY IN PROCEDURE, NO INCISION ENLARGEMENT, NO MEDICAL ATTENTION OR MEDICATION OUTSIDE OF STANDARD CARE WAS PRESCRIBED, NO PATIENT INJURY, NO SUTURE(S), AND NO VITRECTOMY. REPLACEMENT LENS INFORMATION WAS NOT PROVIDED. PATIENT STATUS WAS REPORTED AS FULLY RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608468 TECNIS IOL LENS, INTRAOCULAR, TORIC OPTICS MJP AMO PUERTO RICO MFG. INC. DIU300 05050474747753

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention