BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 1822543 · Received August 27, 2010

    Report

    Report Number
    1119421-2010-00952
    Event Type
    Injury
    Date Received
    August 27, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 28, 2010
    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
    CA, US
    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. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED ON 07/29/2010 AND 08/20/2010 BY PHONE, FAX, AND MAIL. ADDITIONAL INFORMATION WAS OBTAINED BY PHONE. A COMPLETED QUESTIONNAIRE WAS NOT RECEIVED AND WILL NOT BE EXPECTED. P(B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "REFRACTIVE SURPRISE" (POSTOPERATIVE REFRACTION, UNEXPECTED). PRODUCT PROBLEM(S): "DOES NOT FEEL THE LENS IS DEFECTIVE" (NO KNOWN DEVICE PROBLEM [IOL (INTRAOCULAR LENS) IMPLANT]). A SURGEON REPORTED TWO PATIENTS WITH A REFRACTIVE SURPRISE FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE FIRST PATIENT'S REFRACTIVE SURPRISE WAS DUE TO CALCULATION ERROR. IN A FOLLOW-UP WITH THE SURGEON REGARDING THE SECOND PATIENT, HE REPORTED THAT HE DOES NOT SEE ANY OBSERVABLE PROBLEMS WITH THE LENS NOR DOES HE FEEL THE LENS IS DEFECTIVE; AND THAT THE SOURCE OF THE REFRACTIVE ERROR WAS NOT APPARENT. EVENTUALLY, HE STATED THE LENS WAS EXCHANGED FOR THE SAME MODEL, DIFFERENT POWER LENS; AND THE PATIENT NOW HAS GOOD RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN60WF 11003670

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention