BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 24523789 · Received March 5, 2026

    Report

    Report Number
    3012236936-2026-000040
    Event Type
    Malfunction
    Date Received
    March 5, 2026
    Date of Event
    February 10, 2026
    Report Date
    April 8, 2026
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474636149
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D9 - DEVICE AVAILABLE FOR EVALUATION? YES. SECTION D9 - DATE RETURNED TO MANUFACTURER: 05-MAR-2026. SECTION H3 - DEVICE EVALUATED BY MANUFACTURER? YES. DEVICE EVALUATION: VISUAL INSPECTION OF THE COMPLAINT DEVICE REVEALED THAT THE HANDPIECE WAS RECEIVED WITH THE PLUNGER ROD FULLY ADVANCED. VISCOELASTIC RESIDUE WAS OBSERVED THROUGHOUT THE CARTRIDGE. NO ISSUES WERE IDENTIFIED WITH THE CARTRIDGE, LENS MODULE, DEVICE ASSEMBLY, PLUNGER ROD, OR PLUNGER ROD ADVANCEMENT. NO LENS WAS RECEIVED FOR EVALUATION. THE COMPLAINT ISSUE "DELIVERY ISSUE" COULD NOT BE CONFIRMED DURING PRODUCT EVALUATION, AND NO ISSUES WERE IDENTIFIED. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION A2, A3, A4, AND A5: PER REGULATION EU (B)(4) (GENERAL DATA PROTECTION REGULATION), PATIENT IDENTIFIERS WERE NOT COLLECTED OR RECORDED AND THEREFORE ARE NOT AVAILABLE. SECTION D6B - EXPLANT DATE: N/A - LENS REMAINS IMPLANTED; THEREFORE, NOT EXPLANTED. SECTION E1: (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. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING IMPLANTATION OF THE PRELOADED, MONOFOCAL, INTRAOCULAR LENS (IOL) THE HAPTIC BECAME STUCK INSIDE THE CARTRIDGE WHEN THE IOL WAS 90% DELIVERED INTO THE PATIENT'S EYE. THE SURGEON USED FORCEPS TO REMOVE THE IOL FROM THE CARTRIDGE AND POSITION THE HAPTIC WITHIN THE CAPSULAR BAG. THERE WAS NO PATIENT INJURY REPORTED AND NO SURGICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587220 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DCB00 05050474636149

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown