BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 2890980 · Received December 21, 2012

    Report

    Report Number
    1119421-2012-01631
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    May 11, 2012
    Report Date
    November 29, 2012
    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
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. NO ROOT CAUSE COULD BE IDENTIFIED BY THE INVESTIGATION. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT A STUDY PATIENT PRESENTED WITH RAISED IOP (INTRAOCULAR PRESSURE) FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE PATIENT WAS TREATED WITH MEDICATION. THE PATIENT WAS HOSPITALIZED ABOUT SIX MONTHS AFTER THE IOL SURGERY DUE TO A BLADDER INFECTION THAT WAS UNRELATED TO THE STUDY DEVICE OR STUDY PROCEDURE. ADDITIONAL INFORMATION WAS PROVIDED BY THE SURGEON WHO REPORTED THE EVENT PERSISTED AND PROGRESSED TO PRIMARY OPEN ANGLE GLAUCOMA (POAG). THE PATIENT CONTINUES TO BE TREATED WITH MEDICATION. THE SURGEON ALSO INDICATED THAT THE EVENT IS NOT RELATED TO THE STUDY DEVICE OR THE TEST PROCEDURE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./ HUNTINGTON SN60WF 12091334

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention VITAMIN D| SIMVASTATIN| AZOR| ECOTRIN| NEVENAC FROM (B)(6) 2012| COREG| PLAVIX