BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 3231550 · Received July 15, 2013

    Report

    Report Number
    1119421-2013-00756
    Event Type
    Injury
    Date Received
    July 15, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 17, 2013
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THE FILE INDICATED THE USE OF AN UNQUALIFIED VISCOELASTIC IN THE DEVICE. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE FOR "POSTOPERATIVE REFRACTION IS DIFFERENT". A FAILURE TO FOLLOW THE DFU WAS ALSO INDICATED BY THE USE OF AN UNQUALIFIED VISCOELASTIC IN THE DEVICE. THE USE OF AN UNAPPROVED VISCOELASTIC MAY CONTRIBUTE TO MISFOLDING OF THE TRAILING HAPTIC OR OTHER UNPREDICTABLE OUTCOMES, WHICH MAY RESULT IN LENS DAMAGE OR IMPROPER DELIVERY. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON (B)(4) 2013.

    Description of Event or Problem · 1

    A SURGEON REPORTED A PT WITH AN UNEXPECTED POSTOPERATIVE REFRACTION FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE SURGEON WHO REPORTED THAT AT THE PT'S POSTOPERATIVE VISIT, THERE WAS NO INTRAOCULAR LENS IMPLANTS IN THE PT'S EYE. THE PT WAS LEFT APHAKIC. THE SURGEON USED AN UNAPPROVED VISCOELASTIC DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325779 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN6CWS 12029503

    Patients

    Seq Age Sex Outcome Treatment
    1 Other