BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF RESTOR

    MDR report key: 3772312 · Received December 18, 2013

    Report

    Report Number
    1119421-2013-01251
    Event Type
    Malfunction
    Date Received
    December 18, 2013
    Date of Event
    November 20, 2013
    Report Date
    November 20, 2013
    Manufacturer
    ALCON MANUFACTURING, LTD.
    Product Code
    HQL
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE 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. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADD'L INFO BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE WAS NOT RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A MULTIFOCAL INTRAOCULAR LENS (IOL) WAS OBSERVED TO BE DECENTERED AT THE ONE WEEK POSTOPERATIVE VISIT. ADD'L INFO WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664085 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON MANUFACTURING, LTD. SN6AD1 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1