BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 22918730 · Received August 28, 2025

    Report

    Report Number
    3012236936-2025-000228
    Event Type
    Injury
    Date Received
    August 28, 2025
    Date of Event
    May 15, 2025
    Report Date
    August 28, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474558298
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D6B: IF EXPLANTED; GIVE DATE: NOT APPLICABLE AS THE DEVICE REMAINS IMPLANTED. SECTION H3: THE DEVICE WAS NOT RETURNED FOR EVALUATION AS THE LENS REMAINS IMPLANTED; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF RECORDS INCLUDING DEVICE HISTORY AND COMPLAINT TRENDING WILL BE PERFORMED. UPON COMPLETION OF THIS REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION, A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    A PATIENT REPORTED EXPERIENCING BLURRED VISION IN HER LEFT EYE, WHICH HAD A MONOFOCAL INTRAOCULAR LENS (IOL) IMPLANTED. THIS VISUAL IMPAIRMENT HAS AFFECTED HER ABILITY TO RECOGNIZE FACES ON HER TELEVISION. ADDITIONALLY, THE PATIENT OBSERVED A BLACK, FLOATING SPOT IN HER VISION. DESPITE USING OVER-THE-COUNTER EYE DROPS, THE BLURRED VISION PERSISTED. THE PATIENT INDICATED UNDERGOING BILATERAL IOL IMPLANTATION IN 2019. APPROXIMATELY FOUR MONTHS AGO, THE PATIENT NOTICED A BLACK DOT IN HER LEFT EYE, AND TWO MONTHS LATER, HER BLURRY VISION BEGAN. THE PATIENT MENTIONED THAT THIS ISSUE HAS BEEN RESOLVED, AND HER VISION IS CURRENTLY FINE WITH NO ISSUES. AROUND (B)(6) 2025, THE PATIENT RETURNED TO HER DOCTOR WHO REPORTEDLY CLEANED ALL THE GUNK IN HER LEFT EYE USING A LASER TREATMENT. THE PATIENT IS UNCLEAR WHETHER THE CONDITION WAS POSTERIOR CAPSULE OPACIFICATION (PCO) AND IF A YTTRIUM-ALUMINUM-GARNET (YAG) LASER WAS USED, ONLY RECALLING THAT A LASER WAS INVOLVED. THE PATIENT EMPHASIZED THAT ONLY HER LEFT EYE WAS TREATED, AND HER RIGHT EYE IS FINE. SHE CONFIRMED THAT NO ADDITIONAL MEDICATIONS OR PROCEDURES WERE PERFORMED ON HER EYE AT THAT TIME. FURTHER DETAILS WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260803 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. PCB00 05050474558298

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Required Intervention