BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 3318697 · Received August 26, 2013

    Report

    Report Number
    1119421-2013-00901
    Event Type
    Injury
    Date Received
    August 26, 2013
    Date of Event
    January 1, 2013
    Report Date
    August 1, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. 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. NOT ENOUGH INFORMATION WAS PROVIDED FROM THE ACCOUNT FOR FURTHER INVESTIGATION. ATTEMPTS HAVE BEEN MADE TO OBTAIN INFORMATION. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. FOLDEN, D. NEODYMIUM: YAG LASER ANTERIOR CAPSULECTOMY: SURGICAL OPTION IN THE MANAGEMENT OF NEGATIVE "DYSPHOTOPSIA," J CATARACT REFRACT SURG 2013; 39:1110-1115. (B)(4).

    Description of Event or Problem · 1

    THE AUTHOR OF A LITERATURE ARTICLE REPORTED A PATIENT EXPERIENCING "DYSPHOTOPSIA" WITH A PROMINENT DARK TEMPORAL SHADOW ("RIM") EXTENDING THROUGHOUT THE TEMPORAL PERIPHERY IN THE LEFT EYE, FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. A YAG LASER ANTERIOR CAPSULECTOMY WAS PERFORMED THREE (3) MONTHS POSTOPERATIVELY WITH NO IMPROVEMENT IN SYMPTOMS FOLLOWING THE TREATMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416228 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention