BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 1359590 · Received April 10, 2009

    Report

    Report Number
    9612169-2009-00006
    Event Type
    Other
    Date Received
    April 10, 2009
    Date of Event
    January 1, 2009
    Report Date
    March 11, 2009
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    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 HAS BEEN ONE OTHER COMPLAINT REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED. (B) (4). (B) (4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED SEEING "LINES OF LIGHT CLOSELY GROUPED TOGETHER THAT RADIATE OUT" FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY. IN A FOLLOW-UP, THE SURGEON REPORTED THE PT EXPERIENCING POSITIVE DYSPHOTOPSIA. HE ALSO REPORTED NOTICING STRESS MARKS IN THE CTR OF THE IOL OPTIC. IN A POSTOPERATIVE VISIT IN (B) (6) 2009, THE PT HAD A UCVA OF 6/5 (APPROXIMATELY 20/20) AND SYMPTOMS OF POSITIVE DYSPHOTOPSIA REMAIN. THE SURGEON DOES NOT BELIEVE THAT THE STRESS MARKS ON THE IOL ARE CAUSING THE SYMPTOMS OF POSITIVE DYSPHOTOPSIA AND DOES NOT PLAN TO EXCHANGE THE IOL. 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 INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. SN60WF 20809632

    Patients

    Seq Age Sex Outcome Treatment
    1 Other