BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF SINGLEPIECE IOL

    MDR report key: 11746616 · Received April 29, 2021

    Report

    Report Number
    9612169-2021-00098
    Event Type
    Malfunction
    Date Received
    April 29, 2021
    Date of Event
    April 22, 2021
    Report Date
    August 11, 2021
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    HQL
    UDI-DI
    00380652555883
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS RETURNED FOR ANALYSIS AND THE REPORTED COMPLAINT WAS OBSERVED. IOL RETURNED POSITIONED INCORRECTLY IN THE IOL CASE. THE IOL IS IMMERSED IN SOLUTION AND WHAT APPEARS TO BE BLOOD. ONE HAPTIC IS BROKEN/TORN AND NOT RETURNED. THE OTHER HAPTIC IS ADHERED TO THE OPTIC SURFACE WITH SOLUTION. THE OPTIC HAS BEEN CUT HALFWAY THOUGH THE OPTIC AND IS SCRATCHED/MARKED-REJECTABLE. THE COMPLAINANT INDICATES THE USE OF COMPANY VISCOELASTIC, WHICH IS NOT QUALIFIED FOR USE WITH ASSOCIATED IOL MODEL/ CARTRIDGE COMBINATION. WHILE WE ARE UNABLE TO DETERMINE THE ORIGIN OF THE REPORTED COMPLAINT, OUR OBSERVATIONS REASONABLY SUGGEST THAT IT IS NOT MANUFACTURING RELATED. BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER, THE MOST LIKELY ROOT CAUSE IS FAILURE TO FOLLOW DFU, AS THE CUSTOMER STATES THE USE OF NON-QUALIFIED COMBINATION. THE USE OF NONQUALIFIED COMBINATION MAY RESULT IN DELIVERY ISSUES AND/OR DAMAGE. ALL PRODUCT AND BATCH HISTORY RECORDS ARE QUALITY REVIEWED PRIOR TO PRODUCT RELEASE. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. 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 HEALTH PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT SURGERY, THE SURGEON NOTICED A SCRATCH ON THE LENS AFTER IT WAS IMPLANTED. THE SURGEON REMOVED AND REPLACED THE LENS DURING THE INITIAL PROCEDURE. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643759 ACRYSOF SINGLEPIECE IOL INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. SA60AT 21282787 00380652555883

    Patients

    Seq Age Sex Outcome Treatment
    1 MONARCH III HP| MONARCH IOL HP| PROVISC