BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 3896203 · Received June 13, 2014

    Report

    Report Number
    1119421-2014-00451
    Event Type
    Injury
    Date Received
    June 13, 2014
    Report Date
    May 22, 2014
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDED A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MFG DOCUMENTATION. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. NOT ENOUGH INFO WAS PROVIDED FROM THE ACCOUNT FOR FURTHER INVESTIGATION. ADD'L INFO HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PT EXPERIENCED AN HYPEROPIC SHIFT AFTER INTRAOCULAR LENS (IOL) IMPLANTATION. THE PT UNDERWENT BILATERAL SURGERY, THE AFFECTED EYE IS THE LEFT EYE (OS). A REFRACTIVE ENHANCEMENT WITH EXCIMER LASER WAS PERFORMED POSTOPERATIVELY TO MAKE A REFRACTIVE CORRECTION. THIS IS THE THIRD OF FIVE MEDICAL DEVICE REPORTS BEING FILLED FOR THIS FACILITY. ADD'L INFO HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351159 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention