BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2871548 · Received December 6, 2012

    Report

    Report Number
    1119421-2012-01528
    Event Type
    Injury
    Date Received
    December 6, 2012
    Date of Event
    May 11, 2012
    Report Date
    November 6, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. ADDITIONAL INFORMATION WAS PROVIDED, WHICH INDICATED AN APPROVED CARTRIDGE WAS USED. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THERE WERE NO OTHER COMPLAINTS REPORTED IN THE LOT. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT SIX MONTHS FOLLOWING INTRAOCULAR LENS IMPLANT (IOL) SURGERY, THE IOL WAS EXCHANGED DUE TO THE PT BEING UNHAPPY WITH HIS VISION. ADDITIONAL INFORMATION WAS RECEIVED FROM THE SURGEON WHO INDICATED THE PT WAS UNABLE TO DRIVE DUE TO GLARE, STARBURSTS AND HALOS. HE ALSO REPORTED NOTING POSTERIOR CAPSULAR OPACITY (PCO) IMMEDIATELY FOLLOWING THE INITIAL SURGERY. A YAG LASER PROCEDURE WAS PERFORMED AND THE SYMPTOMS WORSENED. THE SURGEON REPORTED THE EVENT RESOLVED FOLLOWING THE LENS EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON RESEARCH, LTD / HUNTINGTON SN6AD1 12072021

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention HANDPIECE| MONARCH CARTRIDGE| DUOVISC