BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 2844573 · Received November 16, 2012

    Report

    Report Number
    9612169-2012-00085
    Event Type
    Injury
    Date Received
    November 16, 2012
    Date of Event
    October 18, 2012
    Report Date
    October 19, 2012
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    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. NO ROOT CAUSE COULD BE IDENTIFIED BY THE INVESTIGATION. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ATTEMPTS TO OBTAIN ADD'L INFO HAVE BEEN MADE. A COMPLETED QUESTIONAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PT WHO EXPERIENCED SEVERE GLARE AT NIGHT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE PT DESCRIBED IT AS "SEVERE GLARES IN NIGHT ABOUT EIGHTEEN FEET IN HEIGHT AROUND LIGHT SOURCE." THE PT ALSO REPORTED DULLNESS OF VISION IN LOW LIGHT CONDITIONS, ESPECIALLY WHEN GOING INSIDE, AFTER BEING IN THE LIGHT, ADDING THAT IT TAKES SOME TIME TO ADJUST THE VISUAL ACUITY. THE SURGEON ADVISED THE PT TO WAIT ONE OR TWO MONTHS AFTER THE SURGERY FOR ADAPTATION TO TAKE PLACE, BUT THE EVENTS DID NOT RESOLVE. THE SURGEON PERFORMED AN OCT (OPTICAL COHERENCE TOMOGRAPHY), ABERROMETRY AND TOPOGRAPHY TO FURTHER EVALUATE THE PT. IT WAS DETERMINED THAT THE PT'S PUPIL SIZE WAS MORE THAN SIX MILLIMETERS IN SCOTOPIC CONDITIONS. THE SURGEON ALSO SUGGESTED THAT THE PT SEEKS THE OPINION OF A SECOND SURGEON. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH THESE EVENTS. THIS REPORT IS FOR THE FIRST EYE. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. SN60WF 21048692

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other