BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF SINGLEPIECE IOL

    MDR report key: 5687663 · Received May 30, 2016

    Report

    Report Number
    9612169-2016-00066
    Event Type
    Injury
    Date Received
    May 30, 2016
    Date of Event
    February 19, 2016
    Report Date
    August 24, 2016
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS RETURNED FOR ANALYSIS. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS RETURNED FOR ANALYSIS AND THE REPORTED COMPLAINT (OPACIFICATION) WAS NOT OBSERVED. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. ADDITIONAL OBSERVATIONS WERE AS FOLLOWS; APPROX. 50% OF THE IOL WAS RETURNED IN A SPECIMEN CONTAINER FILLED WITH A CLEAR UNKNOWN LIQUID. IOL WAS INSPECTED WHILE COVERED IN UNKNOWN LIQUID, OPACIFICATION WAS NOT OBSERVABLE AS IOL WAS COVER IN WET SOLUTION. THE IOL WAS ALLOWED TO AIR DRY AND INSPECTED, OPACIFICATION WAS NOT OBSERVABLE AS IOL WAS COVER IN DRYED SOLUTION. THE IOL WAS CLEANED AND ALLOWED TO AIR DRY, NO OPACIFICATION WAS OBSERVED ON THE CLEANED IOL SEGMENT. THE ROOT CAUSE COULD NOT BE DETERMINED FOR THE REPORTED ¿OPACIFICATION¿. THE RETURNED IOL WAS TORN/CUT, TYPICAL OF DAMAGE OBSERVED WHILE EXPLANTING A LENS. THE RETURNED IOL HAS BEEN IMPLANTED FOR OVER SEVEN (7) YEARS PRIOR TO THE PATIENT REPORTING THE COMPLAINT AND THE IOL HAS BEEN SUBJECTED TO EXTENSIVE HANDLING, TORN/CUT, TYPICAL OF DAMAGE OBSERVED WHILE EXPLANTING AN IOL. (B)(4).

    Description of Event or Problem · 1

    FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A HEALTHCARE PROFESSIONAL REPORTED THE LENS TO BE OPACIFIED. THE LENS WAS EXCHANGED FOR ANOTHER LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342115 ACRYSOF SINGLEPIECE IOL INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. SA60AT 20807507

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other| R