BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 3121803 · Received May 15, 2013

    Report

    Report Number
    1119421-2013-00520
    Event Type
    Injury
    Date Received
    May 15, 2013
    Date of Event
    January 1, 2013
    Report Date
    April 19, 2013
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THE MONARCH CARTRIDGE COULD NOT BE REVIEWED BECAUSE FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MFG DOCUMENTATION. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADD'L INFO. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED ON (B)(4) 2013. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. (B)(4).

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXCHANGED DUE TO LENS DISLOCATION, AND THE PT EXPERIENCING HALOS, LENS WAS REPLACED WITH A MONOFOCAL LENS. ADD'L INFO RECEIVED, THE SURGEON WHO REPORTS THAT AFTER THE LENS WAS EXCHANGED THE OUTCOME IS REPORTED TO HAVE RESOLVED. IT IS UNK IF THE IOL CAUSED OR CONTRIBUTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214829 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN60WF 926621

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention MONARCH III HANDPIECE| MONARCH D CARTRIDGE