BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF TORIC

    MDR report key: 3308526 · Received August 19, 2013

    Report

    Report Number
    1119421-2013-00876
    Event Type
    Injury
    Date Received
    August 19, 2013
    Report Date
    July 22, 2013
    Manufacturer
    ALCON RESEARCH LTD./ HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE PRODUCT HISTORY RECORD 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 FROM THE ACCOUNT FOR FURTHER INVESTIGATION. ADDITIONAL INFO COULD NOT BE OBTAINED, AS THE ARTICLE DID NOT PROVIDE CONTACT INFO FOR THE AUTHOR. CITATION: TIAGO B. FERREIRA, EDUARDO F. MARQUES, ANTONIO RODRIGUES, ROBERT MONTES-MICO. VISUAL AND OPTICAL OUTCOMES OF A DIFFRACTIVE MULTIFOCAL TORIC INTRAOCULAR LENS J CATARACT REFRACT SURG 2013; 39:1029-1035. (B)(4).

    Description of Event or Problem · 1

    THE AUTHOR OF A LITERATURE ARTICLE REPORTED THAT FOLLOWING A BILATERAL INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A PT PRESENTED WITH A SCORE OF THREE (3) FOR GLARE AND HALOS. THE PT HAD "CONSIDERABLE TROUBLE" AS A RESULT. THE PURPOSE OF THE ARTICLE WAS TO EVALUATE THE OUTCOMES OF PT FOLLOWING TORIC INTRAOCULAR LENS (IOL) IMPLANTATION. NO FURTHER INFO IS EXPECTED. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS ARTICLE. THIS REPORT IS FOR THE BILATERALLY IMPLANTED PT, LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401453 ACRYSOF TORIC INTRAOCULAR LENS HQL ALCON RESEARCH LTD./ HUNTINGTON UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other MONARCH III HANDPIECE