BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF IQ TORIC SINGLEPIECE IOL

    MDR report key: 21823887 · Received April 11, 2025

    Report

    Report Number
    9612169-2025-00572
    Event Type
    Malfunction
    Date Received
    April 11, 2025
    Report Date
    July 7, 2025
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A PRODUCT WAS NOT RETURNED FOR ANALYSIS. PROVIDED PHOTOS SHOW AN IMPLANTED INTRAOCULAR LENS (IOL). WHITE IN APPEARANCE MARKS ARE VISIBLE OVER THE IOL SURFACE. NO DETERMINATION CAN BE MADE IF THE WHITE MARKS ARE ON THE IOL SURFACE OR IF THEY ARE ON ANTERIOR OR POSTERIOR SIDE OF THE IOL. NO DETERMINATION CAN BE MADE FROM THE PHOTO EVALUATION. COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS WERE REVIEWED AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE HAS NOT BEEN IDENTIFIED. THIS PRODUCT IS NOT APPROVED OR INTRODUCED INTO COMMERCIAL DISTRIBUTION IN THE UNITED STATES. HOWEVER, THIS MEDWATCH IS BEING FILED BASED ON A SIMILAR PRODUCT SN6AT3-T9 THAT IS SOLD IN THE UNITED STATES UNDER (PMA/510(K) # P930014. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS PROVIDED IN H.3. AND H.11. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. ONLY PHOTOS WERE RETURNED. PHOTO REVIEW: THE FIRST IMAGE IN THE PDF IS OF THE LABELS FOR THE INTRAOCULAR LENSES (IOLS). THEY ARE BOTH COMPANY TORIC WITH UV BLUE FILTERS. THE FIRST IS A COMPANY 14.5 1.00 CYLINDER (CYL). THE SECOND IS COMPANY 13.5 2.25 CYL. THE SECOND IMAGE IS A DILATED EYE WITH A TORIC INTRAOCULAR LENS (IOL) AXIS APPROXIMATELY 70 DEGREES. THE LENS APPEARS CLEAR WITH PERIPHERAL FIBROSIS AROUND THE ANTERIOR CAPSULE. THE THIRD IMAGE IS OF A DILATED EYE WITH A TORIC IOL AXIS APPROXIMATELY 100 DEGREES. THE LENS APPEARS TO BE SLIGHTLY CLOUDED OR YELLOWED WITH SLIGHT GLISTENING AND PERIPHERAL FIBROSIS AROUND THE ANTERIOR CAPSULE. GLISTENING IS A KNOWN SIDE EFFECT OF COMPANY LENSES. FLUID-FILLED MICROVACUOLES CAN FORM WITHIN THE IOL MATERIAL OVER TIME. THIS CAN POTENTIALLY ALTER LIGHT TRANSMISSION AND CAN CAUSE A PERCEPTION OF HAZE OR DISCOLORATION. IN SEVERE CASES IT MAY EFFECT VISION QUALITY. THE ROOT CAUSE FOR THE REPORTED COMPLAINT COULD NOT BE DETERMINED. BASED ON THE RESULTS FROM THE PRODUCT HISTORY RECORD, THE PRODUCTS MET RELEASE CRITERIA. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A PATIENT WENT TO THE CLINIC COMPLAINING OF DECREASED VISION IN RIGHT EYE. EVERY YEAR, THE PATIENT WAS OBSERVED IN THE CLINIC AND THE VISION IN RIGHT EYE WAS 1.0. DURING CURRENT VISIT THE VISION DECREASED TO 0.7. DURING THE SLIT LAMP EXAMINATION, THE SURGEON SAW GLISTENING ON LENS AND THE LENS WAS DIFFERENT IN COLOR, IT WAS CLOUDIER AND YELLOWER. NO SECONDARY CATARACT WAS FOUND IN THE PATIENT, THERE ARE NO PROBLEMS WITH THE RETINA. THE PATIENT HAS BEEN RELEASED FOR THREE MONTHS SO FAR. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1104093 ACRYSOF IQ TORIC SINGLEPIECE IOL INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. SN6AT2 21234139

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown