BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 1941837 · Received December 17, 2010

    Report

    Report Number
    1119421-2010-01436
    Event Type
    Other
    Date Received
    December 17, 2010
    Date of Event
    January 1, 2010
    Report Date
    November 18, 2010
    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
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE DEVICE REMAINS IMPLANTED. 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 INFO WAS REQUESTED ON 12/14/2010 BY FAX AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PT WITH AN UNEXPECTED OUTCOME FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE SURGEON EXPLAINED THAT WHILE DOING THE CCC (CAPSULORRHEXIS) THE CAPSULE SPLIT; AND SWITCHED TO A DIFFERENT MODEL LENS FOR IMPLANTATION IN THE SULCUS. THE IOL WAS LOADED UPSIDE DOWN AND THUS, IMPLANTED REVERSED IN THE SULCUS. ALSO, THE IOL HAPTIC WAS NOTED TO BE CAPTURED IN THE IRIS. DUE TO THESE CIRCUMSTANCES, THE LENS VAULTED FORWARD RESULTING IN A VERY SHALLOW ANTERIOR CHAMBER AND A -3.00D OF MYOPIA (ORIGINAL TARGET REFRACTION WAS PLANO) THAT THE PT HAS DECIDED THAT HE IS VERY HAPPY WITH DUE TO J1+ NEAR VISION. THE SURGEON DOES NOT THINK THE IOL IS DEFECTIVE AND THAT THE REASON FOR THE EVENT WAS THAT THE LENS WAS LOADED UPSIDE DOWN IN THE CARTRIDGE. ADDITIONALLY, THE SURGEON REPORTED THAT, DUE TO THE FACT THAT THE CATARACT WAS SO DENSE, SHE IS NOT CONFIDENT THE CONTACT A-SCAN IS COMPLETELY ACCURATE. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON MN60AC 10852262

    Patients

    Seq Age Sex Outcome Treatment
    1 Other