BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1852405 · Received September 28, 2010

    Report

    Report Number
    1119421-2010-01062
    Event Type
    Injury
    Date Received
    September 28, 2010
    Date of Event
    January 1, 2010
    Report Date
    August 29, 2010
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 INFORMATION WAS REQUESTED ON 08/31/2010, 09/17/2010, AND 09/21/2010 BY PHONE, FAX, AND MAIL. MEDICAL RECORDS WERE REC'D ON 08/30/2010. ADDITIONAL INFORMATION WAS OBTAINED BY PHONE. A COMPLETED QUESTIONNAIRE WAS NOT REC'D. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A PT CANNOT READ BUT HAS EXCELLENT DISTANCE VISION. HE REPORTED THAT PT HAVING RESIDUAL ASTIGMATISM DESPITE LIMBAL RELAXING INCISIONS (LRI) PERFORMED POSTOPERATIVELY. GLASSES WERE ALSO PRESCRIBED, AS WELL AS, TREATMENT WITH MEDICATION (TRIAL) TO CORRECT THE ASTIGMATISM; BUT THERE WAS NO IMPROVEMENT. IN A FOLLOW-UP, THE SURGEON REPORTED THAT THE PT IS SUPPRESSING NEAR VISION DUE TO UNILATERAL IMPLANTATION IN THE NON-DOMINANT EYE/CATARACT IN DOMINANT EYE. HE STATED THAT HE IS NOT BLAMING THE IOL FOR THE EVENT. HE CONTINUES TO WORK WITH THE PT TOWARDS A RESOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD. / HUNTINGTON SN6AD1 10938163

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention