BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 3830085 · Received May 1, 2014

    Report

    Report Number
    9612169-2014-00052
    Event Type
    Injury
    Date Received
    May 1, 2014
    Report Date
    April 3, 2014
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: INVESTIGATION INCLUDING THE ROOT CAUSE ANALYSIS IS IN PROGRESS. THE PRODUCT WAS RETURNED FOR ANALYSIS AND IS PENDING EVALUATION. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE LENS MET RELEASE CRITERIA. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT SURGERY THE PATIENT EXPERIENCED A POSTERIOR CAPSULAR TEAR AND THE IOL HAD TO BE EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261833 ACRYSOF INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. SA60AT 21091579

    Patients

    Seq Age Sex Outcome Treatment
    1 Other