BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PURESEE IOL

    MDR report key: 24801664 · Received April 7, 2026

    Report

    Report Number
    3012236936-2026-000087
    Event Type
    Malfunction
    Date Received
    April 7, 2026
    Report Date
    April 7, 2026
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    MFK
    UDI-DI
    05050474815025
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2, A3A, A3B, A4, A5 AND A6: UNKNOWN/INFORMATION NOT PROVIDED. SECTION B3: DATE OF EVENT: UNKNOWN/INFORMATION NOT PROVIDED. SECTION D6A: IF IMPLANTED, GIVE DATE: UNKNOWN, INFORMATION NOT PROVIDED. SECTION D6B: IF EXPLANTED, GIVE DATE: NOT APPLICABLE, REMAINS IMPLANTED IN THE EYE. SECTION E1: INITIAL REPORTER: EMAIL ADDRESS: UNKNOWN, INFORMATION NOT PROVIDED. SECTION E1: INITIAL REPORTER: 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 AND COMPLAINT HISTORY FOR PRODUCTION ORDER FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE 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

    IT WAS REPORTED THAT THE HAPTICS OF THE PRELOADED TORIC INTRAOCULAR LENS HAD BEEN STUCK FOR AN EXTENDED PERIOD, NECESSITATING ADDITIONAL MANEUVERS WITH TWO INSTRUMENTS TO RELEASE THEM. ADDITIONAL INFORMATION INDICATED THAT THE LENS HAD BEEN STORED AT 22°C WHILE THE OPERATING ROOM TEMPERATURE WAS 18°C, AND IT HAD NOT BEEN WARMED BEFORE THE PROCEDURE. IT HAD BEEN PREPARED BY WASHING WITH BALANCED SALT SOLUTION AND VISCOAT OPHTHALMIC VISCOELASTIC DEVICES, BOTH MAINTAINED AT 18¿20°C, AND IT HAD REMAINED IN THE CARTRIDGE FOR LESS THAN TWO MINUTES. THE SITE HAD BEEN USING THESE DEVICES FOR OVER A YEAR, AND THE LENS HAD NOT BEEN FOLDED FOR MORE THAN TEN MINUTES. NO PATIENT INJURY, CAPSULAR TEAR, OR UNPLANNED SURGICAL INTERVENTIONS SUCH AS VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES OCCURRED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    867936 PURESEE IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO PUERTO RICO MFG. INC. DET150 05050474815025

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown