BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ NATURAL SINGLEPIECE IOL

    MDR report key: 6191466 · Received December 20, 2016

    Report

    Report Number
    9612169-2016-00174
    Event Type
    Injury
    Date Received
    December 20, 2016
    Date of Event
    February 1, 2013
    Report Date
    December 20, 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
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. COMPLAINT HISTORY AND PRODUCT HISTORY RECORD COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A VALID LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. THE ROOT CAUSE HAS NOT BEEN IDENTIFIED. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. (B)(4).

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED THAT ON THE FIRST POST-OPERATIVE VISIT FOLLOWING AN INTRAOCULAR LENS IMPLANT (IOL) PROCEDURE THREE YEARS AGO, A PATIENT COMPLAINED ABOUT VISION QUALITY. THE PATIENT RETURNED IN (B)(6) 2016, AND THE PHYSICIAN NOTED GLISTENINGS OF THE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840569 ACRYSOF IQ NATURAL SINGLEPIECE IOL INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. SN60WF ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other