BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 3812581 · Received May 7, 2014

    Report

    Report Number
    9612169-2014-00053
    Event Type
    Injury
    Date Received
    May 7, 2014
    Report Date
    March 17, 2014
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THE ROOT CAUSE FOR THE REPORTED COMPLAINT COULD NOT BE DETERMINED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. BASED ON THE RESULTS FROM THE PRODUCT AND BATCH HISTORY RECORD, THE PRODUCT MET RELEASE CRITERIA. (B)(4).

    Description of Event or Problem · 1

    AN OPHTHALMIC SURGEON REPORTED A PT SHOWED A SUSPECTED OPACIFICATION OF AN IMPLANTED INTRAOCULAR LENS (IOL). ACCORDING TO THE SURGEON, THE PATIENT'S VISUAL ACUITY WAS AFFECTED BY THE OPACIFICATION OF THE LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275363 ACRYSOF INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. SN60WF 20908368

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other