BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 16561296 · Received March 16, 2023

    Report

    Report Number
    3012236936-2023-00676
    Event Type
    Injury
    Date Received
    March 16, 2023
    Report Date
    April 17, 2023
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    MFK
    UDI-DI
    05050474750661
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT A NON-JOHNSON AND JOHNSON INTRAOCULAR LENS (IOL) WAS IMPLANTED AS REPLACEMENT. THERE WAS NO PATIENT INJURY AND NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THE PATIENT IS DOING FINE POST-OPERATIVELY WITH BEST CORRECT VISUAL ACUITY 20/25 WITH SOME DRY EYE SYMPTOMS. NO FURTHER INFORMATION WAS PROVIDED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN; THE BEST ESTIMATE DATE IS BETWEEN ON (B)(6) 2021 AND ON (B)(6) 2023. 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, AND RISK DOCUMENTATION 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 WERE MADE TO OBTAIN THE MISSING INFORMATION AND PRODUCT AVAILABILITY FOR RETURN; HOWEVER, NO ADDITIONAL INFORMATION 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 THE INTRAOCULAR LENS (IOL) WILL BE EXPLANTED IN TWO TO FOUR WEEKS. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE LENS WAS EXPLANTED FROM THE RIGHT EYE ON (B)(6) 2023 DUE TO BLURRY VISION AND HALOS AT NIGHT (DESPITE SPECTACLE CORRECTION). THE ISSUE STARTED IMMEDIATELY AFTER SURGERY, BUT IT WAS HOPED THAT THE PATIENT WOULD NEURO-ADAPT. THE PATIENT HAD STOPPED DRIVING AT NIGHT DUE TO THE VISUAL ISSUES. THE PATIENT'S PRE-OPERATIVE VISUAL ACUITY (VA) WAS 20/50. THE VA AFTER INITIAL IMPLANT WAS 20/20-1 (VERY BLURRY AND HAZY). NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825517 TECNIS IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO PUERTO RICO MFG. INC. DFR00V 05050474750661

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention