BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 2070130 · Received April 22, 2011

    Report

    Report Number
    9612169-2011-00017
    Event Type
    Injury
    Date Received
    April 22, 2011
    Date of Event
    March 22, 2011
    Report Date
    March 23, 2011
    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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVAL: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED, THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE: THE ROOT CAUSE FOR THE REPORTED COMPLAINT COULD NOT BE DETERMINED AS NO PRODUCT WAS RETURNED FOR ANALYSIS. BASED ON THE RESULTS FROM THE PRODUCT AND BATCH HISTORY RECORD, THE PRODUCT MET RELEASE CRITERIA. ACTIONS: THERE HAVE BEEN NO OTHER COMPLAINTS FOR THIS LOT. NO FURTHER ACTION IS WARRANTED AT THIS TIME. ADDITIONAL INFO HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT FOLLOWING INSERTION OF AN INTRAOCULAR LENS (IOL), WHITE GRANULES LIKE SAND WERE NOTED ENCRUSTED IN THE HAPTIC. THE INCISION WAS ENLARGED AND THE IOL WAS REMOVED AND REPLACED. THE SURGEON REPORTED SOME CORNEAL EDEMA HAD BEEN NOTED WHICH HE EXPECTED TO DIMINISH. SUTURES WERE PLACED TO CLOSE THE INCISION. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. SN60WF 21022916

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention