BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2861323 · Received December 5, 2012

    Report

    Report Number
    1119421-2012-01507
    Event Type
    Injury
    Date Received
    December 5, 2012
    Date of Event
    August 1, 2008
    Report Date
    November 5, 2012
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THE PRODUCT INVESTIGATED COULD NOT IDENTIFY A ROOT CAUSE. THERE HAVE BEEN TWO OTHER SIMILAR COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFO WAS REQUESTED ON (B)(4) 2012, BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER, WHO IS ALSO THE SURGERY DIRECTOR, REPORTED THAT FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERIES, SHE HAS BLURRY VISION AND IS EXPERIENCING HALOS FROM BOTH EYES. SHE STATED THAT YAG PROCEDURES WERE PERFORMED ON EACH EYE WITHIN ONE MONTH OF IMPLANTATION. SHE REPORTED A HISTORY OF LASIK 10 YEARS BEFORE THE IMPLANT SURGERIES. ADDITIONAL INFO HAS BEEN REQUESTED. 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 RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD. / HUNTINGTON SN6AD3 10774748

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention