BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2894780 · Received December 20, 2012

    Report

    Report Number
    1119421-2012-01602
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    January 1, 2011
    Report Date
    November 21, 2012
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    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 INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFO WAS REQUESTED ON 11/27/2012 AND 12/12/2012 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY, HE EXPERIENCED BLURRY VISION AT ALL DISTANCES, HALOS, DRY EYES AND FLOATERS. HE REPORTED THE PRESCRIPTION GLASSES DO NOT HELP AND HIS SYMPTOMS ARE AFFECTING HIS JOB AS A CARPENTER. APPROX SIX MONTHS AFTER THE IMPLANT SURGERY, A YAG LASER WAS PERFORMED FOR A SECONDARY CATARACT IN THE RIGHT EYE, WITH NO IMPROVEMENT. THE CONSUMER REPORTED HE HAS SOUGHT A SECOND OPINION. ADDITIONAL INFO HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN6AD1 11008350

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other