BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 3062785 · Received April 11, 2013

    Report

    Report Number
    1119421-2013-00387
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    December 1, 2012
    Report Date
    March 15, 2013
    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
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION 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 HAS BEEN ONE OTHER COMPLAINT REPORTED IN THE LOT NUMBER. AT THE CONSUMER'S REQUEST, THE SURGEON WAS NOT CONTACTED. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT HER VISION GRADUALLY DECLINED IN BOTH EYES, FOLLOWING BILATERAL, MULTIFOCAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY. SHE STATED THAT INITIALLY HER VISION WAS PERFECT AT ALL RANGES. THEN HER VISION DECLINED AT NEAR AND INTERMEDIATE RANGE AND A HAZE DEVELOPED. A YAG CAPSULOTOMY WAS PERFORMED, WHICH HELPED WITH THE HAZE. CURRENTLY, HER VISION CONTINUES TO BE BLURRY, SHE SEES TWO IMAGES (IMAGES HAVE A SHADOW), REQUIRES READING GLASSES, AND EXPERIENCES STARBURSTS AT NIGHT. THE SURGEON HAS TREATED HER FOR DRY EYES AND HAS SUGGESTED REFRACTIVE ENHANCEMENT, ALTHOUGH NO INTERVENTION HAS BEEN SCHEDULED. AT THE REQUEST OF THE CONSUMER, THE SURGEON WAS NOT CONTACTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE FIRST EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155105 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./ HUNTINGTON SN6AD1 12001652

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention