BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2930351 · Received January 22, 2013

    Report

    Report Number
    1119421-2013-00061
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    January 1, 2012
    Report Date
    December 24, 2012
    Manufacturer
    ALCON MANUFACTURING, LTD./ HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P040020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. NOT ENOUGH INFORMATION WAS PROVIDED TO PROPERLY COMPLETE AN INVESTIGATION. PENGC, ZHAO J, MA L, QU B, SUN Q, ZHANG J. OPTICAL PERFORMANCE AFTER BILATERAL IMPLANTATION OF APODIZED ASPHERIC DIFFRACTIVE MULTIFOCAL INTRAOCULAR LENSES WITH +3.00-D ADDITION POWER. ACTA OPHTHALMOLOGICA SCANDINAVICA FOUNDATION; 2012; 90: E586-E593. (B)(4).

    Description of Event or Problem · 1

    A JOURNAL ARTICLE REPORTED THE RESULTS OF A STUDY THAT COMPARED THE VISUAL AND OPTICAL PERFORMANCE OF MULTIFOCAL INTRAOCULAR LENSES (IOLS) WITH THE STANDARD ASPHERIC MONOFOCAL IOLS. WHEN IMPLANTED BILATERALLY, THE ARTICLE STATES THAT THE FOLLOWING VISUAL DISTURBANCES WERE REPORTED BY PATIENTS IN BOTH GROUPS: GLARE/FLARE, PROBLEMS WITH NIGHT VISION, HALOS DISTORTED NEAR VISION, DISTORTED FAR VISION, BLURRED NEAR VISION, BLURRED FAR VISION, PROBLEMS WITH COLOR VISION, AND DOUBLE VISION WITH BOTH EYES. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, THE SURGEON WAS UNABLE TO PROVIDE FURTHER DETAILS. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE PATIENTS IN THE MULTIFOCAL IOL GROUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30092 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON MANUFACTURING, LTD./ HUNTINGTON SN6AD1 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other