BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ NATURAL SINGLEPIECE IOL

    MDR report key: 25253429 · Received May 22, 2026

    Report

    Report Number
    9612169-2026-01190
    Event Type
    Injury
    Date Received
    May 22, 2026
    Date of Event
    April 13, 2026
    Report Date
    May 22, 2026
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    HQL
    UDI-DI
    00380655093191
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE LENS REMAINS IMPLANTED. COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS WERE REVIEWED AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE HAS NOT BEEN IDENTIFIED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED THAT FOLLOWING A CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A ROUTINE CATARACT PATIENT WITH NO SPECIAL CONDITIONS UNDERWENT SURGERY. THE SURGERY WAS COMPLETED SMOOTHLY ON THE DAY OF OPERATION. POSTOPERATIVELY, THE PATIENT DEVELOPED TOXIC ANTERIOR SEGMENT SYNDROME (TASS). ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT CATARACT SURGERY HAD BEEN PERFORMED ON THE LEFT EYE OF AN ELDERLY PATIENT. TWELVE DAYS AFTER THE SURGERY, THE PATIENT EXPERIENCED REDNESS, PAIN, A FOREIGN BODY SENSATION, AND BLURRED VISION IN THE LEFT EYE. THE CONDITION WAS CONSIDERED TO BE TOXIC ANTERIOR SEGMENT SYNDROME OF THE LEFT EYE, WHICH WAS RELATED TO INTRAOCULAR LENS (IOL) IMPLANTATION. LOCAL HORMONE EYE DROPS WERE ADMINISTERED, ALONG WITH A TOPICAL INJECTION OF CORTICOSTEROID AND THE CONDITION IMPROVED AFTER SYSTEMIC INTRAVENOUS CORTICOSTEROID INFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368102 ACRYSOF IQ NATURAL SINGLEPIECE IOL INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. SN60WF 26081783 00380655093191

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention| O