BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 22007078 · Received May 12, 2025

    Report

    Report Number
    3012236936-2025-000136
    Event Type
    Injury
    Date Received
    May 12, 2025
    Date of Event
    November 6, 2024
    Report Date
    May 12, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    MFK
    UDI-DI
    05050474709799
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A6: UNKNOWN/ASKED BUT UNAVAILABLE (ASKU). SECTION E1: TELEPHONE NUMBER: (B)(6). SECTION H3: THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT TRENDING, FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION. HOWEVER, THE ACCOUNT DID NOT HAVE THE INFORMATION. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S OPERATIVE EYE DUE TO NON-ADAPTING TO THE TRIFOCAL. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED. ANOTHER JOHNSON & JOHNSON LENS, MODEL DIB00 16.5 DIOPTER WAS IMPLANTED AS A REPLACEMENT. THE PATIENT¿S STATUS FOLLOWING THE PROCEDURE WAS REPORTED AS UNKNOWN. THROUGH FOLLOW UP, IT WAS LEARNED THAT THE PATIENT WAS NOT ABLE TO ADAPT AS THE PATIENT HAD FLUCTUATIONS IN VISION AND THE QUALITY OF VISION WAS UNSATISFACTORY. THE PATIENT'S VISION WAS BLURRY AT ALL DISTANCES DESPITE HAVING NO REFRACTIVE ERROR. IT WAS CONFIRMED THERE WAS NO PATIENT INJURY. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION OUTSIDE OF THE STANDARD CARE. THE PATIENT IS DOING FINE POST-OPERATIVELY WITH THE REPLACEMENT LENS. THE LENS IS NOT AVAILABLE FOR RETURN AS IT WAS NOT SAVED ONCE IT WAS EXPLANTED. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2300511 TECNIS IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO PUERTO RICO MFG. INC. DFR00V 05050474709799

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention