BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2932228 · Received January 25, 2013

    Report

    Report Number
    1119421-2013-00069
    Event Type
    Injury
    Date Received
    January 25, 2013
    Date of Event
    August 4, 2011
    Report Date
    December 29, 2012
    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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADD¿L INFO. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON (B)(4) 2012. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY, THE PATIENT REPORTED EXPERIENCING CONSTANT GLARE NIGHT AND DAY. THE PATIENT HAD AN INTRALASE PROCEDURE PERFORMED ON BOTH EYES FOLLOWING THE IMPLANT PROCEDURE. POSTERIOR CAPSULE OPACIFICATION WAS ALSO NOTED. FOR THIS EYE, THE LENS HAS BEEN EXCHANGED. ADD¿L INFO HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35890 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON RESEARCH LTD./ HUNTINGTON SN6AD1 12030081

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention MONARCH II HANDPIECE| MONARCH D CARTRIDGE| PROVISC