BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 3925442 · Received June 18, 2014

    Report

    Report Number
    1119421-2014-00475
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    February 6, 2014
    Report Date
    May 1, 2014
    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
    NC, 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. ADDITIONAL INFO WAS PROVIDED WHICH INDICATED AN APPROVED CARTRIDGE WAS USED; HOWEVER, AN UNAPPROVED VISCOELASTIC WAS USED. NOT ENOUGH INFO WAS PROVIDED TO CONDUCT A REVIEW ON THE CARTRIDGE LOT. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFO BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A PT EXPERIENCED BLURRY VISION AT NEAR. THE IOL WAS EXCHANGED THREE MONTHS LATER FOR ANOTHER LENS MODEL. THE SURGEON INDICATED THE USE OF AN INCORRECT VISCOELASTIC DURING THE IMPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356752 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN6AD1 12262786

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention HEALON GV| PUNCTAL PLUGS| MONARCH D CARTRIDGE| RESTASIS| ARTIFICIAL TEARS