BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 3841025 · Received May 14, 2014

    Report

    Report Number
    1119421-2014-00330
    Event Type
    Injury
    Date Received
    May 14, 2014
    Date of Event
    February 12, 2014
    Report Date
    April 17, 2014
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    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 INFO BECOMES AVAILABLE. ADDITIONAL INFO HAS BEEN REQUESTED TO THE CUSTOMER, BUT NOT RECEIVED TO DATE. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL PHARMACIST REPORTED AN INTRAOCULAR LENS (IOL) WAS REMOVED DURING SURGERY FOLLOWING A POSTERIOR CAPSULE TEAR. THE REPORTER WAS NOT ABLE TO PROVIDE FURTHER DETAILS. ADDITIONAL INFO HAS BEEN REQUESTED TO THE CUSTOMER, BUT NOT RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288020 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON MA60AC 11059761

    Patients

    Seq Age Sex Outcome Treatment
    1 Other