BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2871542 · Received December 6, 2012

    Report

    Report Number
    1119421-2012-01518
    Event Type
    Injury
    Date Received
    December 6, 2012
    Date of Event
    January 1, 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
    HU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER 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 FROM THE REPORTER TO PROPERLY COMPLETE AND INVESTIGATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT TWO PATIENTS (MARRIED COUPLE) UNDERWENT UNEVENTFUL BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY WITH MULTIFOCAL IOLS IMPLANTED FOR REFRACTIVE PURPOSES DUE TO SLIGHT HYPERMETROPY AND PRESBYOPIA. INFORMATION WAS RECEIVED FOR THE MALE PATIENT WHICH INDICATED THAT SHORTLY AFTER SURGERY HE DID NOT FEEL COMFORTABLE WITH HIS VISION. HE REPORTED THAT METALLICA OBJECTS WERE GLITTERING AND HALOS WERE SEEN AROUND ILLUMINANTS. HE COULD NOT SEE THE COMPUTER SCREEN CLEARLY, AND READING WAS ONLY POSSIBLE WITH THE USE OF STRONG LIGHT AND HIGH CONTRAST TEXT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE FOUR MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE MALE PATIENT, LEFT EYE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other BETALOC ZOK (METROPOLOL)| TRITACE HCT (HYDROCHLOROTHIAZIDE AND RAMIPRIL)| MEMORIL, RIVOTRIL (CLONAZEPAM)- DATE UNKNOWN| ASPIRIN PROTECT (ACETYLSALICYLIC ACID)