BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 16449468 · Received February 27, 2023

    Report

    Report Number
    3012236936-2023-00358
    Event Type
    Injury
    Date Received
    February 27, 2023
    Date of Event
    January 13, 2023
    Report Date
    April 17, 2023
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    UDI-DI
    05050474711693
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION: THE INCORRECT EVENT DATE WAS INADVERTENTLY REPORTED IN THE INITIAL MDR. THE CORRECT DATE OF EVENT IS JANUARY 13, 2023. THE FIELD BELOW HAS BEEN UPDATED: SECTION B3 - DATE OF EVENT: JANUARY 13, 2023 ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    PER REGULATION EU (B)(4) (GENERAL DATA PROTECTION REGULATION), PATIENT IDENTIFIERS WERE NOT COLLECTED OR RECORDED AND THEREFORE ARE NOT AVAILABLE. IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS THE LENS REMAINS IMPLANTED. INITIAL REPORTER TELEPHONE NUMBER: (B)(6). DEVICE EVALUATION: PRODUCT TESTING COULD NOT BE PERFORMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT REMAINS IMPLANTED. 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. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANTATION A PATIENT HAD UNEXPECTED RESULTS DURING POST-OPERATIVE CHECK-UP: EYE WITH EDEMA AND PRESENCE OF CYCLITIC MEMBRANE THROUGH FURTHER FOLLOW-UPS WE LEARNED THAT IT WAS A DIFFUSE EDEMA WITH DESCEMET FOLDS. MEDICAL INTERVENTION WAS PERFORMED. THE PATIENT IS IMPROVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381621 TECNIS IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS DFW225 05050474711693

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention