BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PURESEE IOL

    MDR report key: 25247454 · Received May 21, 2026

    Report

    Report Number
    3012236936-2026-000139
    Event Type
    Injury
    Date Received
    May 21, 2026
    Date of Event
    April 17, 2026
    Report Date
    May 21, 2026
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    MFK
    UDI-DI
    05050474814387
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2, A3, A4, AND A5: UNKNOWN, AS INFORMATION WAS REQUESTED BUT NOT PROVIDED. SECTION D6B - EXPLANT DATE: NOT APPLICABLE - LENS REMAINS IMPLANTED; THEREFORE, NOT EXPLANTED. SECTION E1 - EMAIL ADDRESS: UNKNOWN/NOT PROVIDED. 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 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. ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION. HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TWO PURESEE INTRAOCULAR LENSES (IOLS) WERE IMPLANTED IN BOTH EYES, AND RIGHT AFTER IMPLANTATION THE PATIENT PRESENTED WITHOUT INTERMEDIATE VISION OR NEAR VISION IN BOTH EYES. THE PRE AND POST-SURGICAL OPTICAL COHERENCE TOMOGRAPHY (OCT) WAS REQUESTED, THE PATIENT'S RETINA HAD NO PROBLEM, CAVITATION AND OPTIC NERVE WERE ALSO NORMAL. THERE WAS NO PREVIOUS CORNEAL SURGERY. THE LENSES REMAIN IMPLANTED. THE PATIENT IS BEING MONITORED. NO FURTHER INFORMATION WAS PROVIDED. NOTE: THIS REPORT IS FOR THE IOL IMPLANTED IN THE PATIENT'S LEFT EYE. THE REPORT SUBMITTED FOR THE PATIENT'S RIGHT EYE NUMBER IS 3012236936-2026-0001398. .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275073 PURESEE IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO PUERTO RICO MFG. INC. DET100 05050474814387

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other