BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF IQ NATURAL SINGLEPIECE IOL

    MDR report key: 21094372 · Received January 7, 2025

    Report

    Report Number
    9612169-2025-00056
    Event Type
    Malfunction
    Date Received
    January 7, 2025
    Report Date
    March 14, 2025
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    HQL
    UDI-DI
    00380655093160
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A PRODUCT WAS NOT RETURNED FOR ANALYSIS. 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).

    Additional Manufacturer Narrative · 0

    CORRECTION INFORMATION WAS PROVIDED IN H.6. AND H.11. ADDITIONAL INFORMATION WAS PROVIDED IN B.5. CORRECTION: ON INITIAL MDR THE PRODUCT CODE OF A050301 WAS AN ERROR. IT SHOULD HAVE BEEN A140504 ON THE ORIGINAL MDR. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL REPORTED WITH THE DESCRIPTION OF WHEN THE SURGEON WAS DOING A WOUND ASSISTED INSERTION OF THE LENS, THE INTRAOCULAR LENS WAS HALF IN AND HALF OUT OF THE EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED AND STATED THAT, THE SURGEON WAS DOING WOUND ASSISTED INSERTION OF THE LENS AND HE MUST HAVE RELEASED PRESSURE AS THE LENS WAS THEREFORE HALF IN AND HALF OUT OF THE EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1104703 ACRYSOF IQ NATURAL SINGLEPIECE IOL INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. SN60WF 25726829 00380655093160

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown