BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF SINGLEPIECE IOL

    MDR report key: 11653369 · Received April 12, 2021

    Report

    Report Number
    9612169-2021-00082
    Event Type
    Malfunction
    Date Received
    April 12, 2021
    Date of Event
    March 18, 2021
    Report Date
    June 10, 2021
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    HQL
    UDI-DI
    00380652555838
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE COMPLAINANT STATES THE USE OF CARTRIDGE WHICH IS NOT QUALIFIED TO BE USED WITH THE ASSOCIATED IOL MODEL. THE REPORTED COMPLAINT WAS NOT OBSERVED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. HOWEVER, BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER, THE MOST LIKELY ROOT CAUSE IS FAILURE TO FOLLOW THE DIRECTIONS FOR USE, AS THE SURGEON STATES THE USE OF NON-QUALIFIED COMBINATION. THE USE OF NON-QUALIFIED COMBINATIONS MAY RESULT IN DELIVERY ISSUES AND/OR DAMAGE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE PRODUCT HISTORY AND BATCH RECORDS WERE REVIEWED AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, TWO LENSES CRACKED UPON INSERTION. THE SURGEON WAS ABLE TO REMOVE BOTH LENSES WITHOUT INCIDENT. A 3RD LENS WAS USED TO COMPLETE THE PROCEDURE. IN THE SURGEON'S OPINION THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO A SERIOUS PATIENT INJURY. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS SURGERY. THIS EVENT WAS FOR ONE OF THE TWO CRACKED LENSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551180 ACRYSOF SINGLEPIECE IOL INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. SA60AT 21269633 00380652555838

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR DUOVISC VISCOELASTIC SYSTEM| MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D| MONARCH III IOL DELIVERY SYSTEM, INJECTOR