BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF TORIC

    MDR report key: 2705870 · Received August 17, 2012

    Report

    Report Number
    1119421-2012-01026
    Event Type
    Injury
    Date Received
    August 17, 2012
    Date of Event
    May 10, 2011
    Report Date
    July 17, 2012
    Manufacturer
    ALCON RESEARCH, LTD./ HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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 REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MFG DOCUMENTATION. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. NOT ENOUGH INFO WAS PROVIDED FROM THE ACCOUNT TO PROPERLY COMPLETE AN INVESTIGATION. ADD'L INFO WAS REQUESTED BY PHONE, FAX AND MAIL. A COMPLETED QUESTIONNAIRE WAS REC'D. ROENSCH A, CHARTON J, BLOMQUIST P, AGGARWAL N, MCCULLEY J. RESIDENT EXPERIENCE WITH TORIC AND MULTIFOCAL INTRAOCULAR LENSES IN A PUBLIC COUNTY HOSPITAL SYSTEM. J CATARACT REFRACT SURG 2012; 38:793. (B)(4).

    Description of Event or Problem · 1

    IN A JOURNAL ARTICLE, THE AUTHORS PRESENTED THE OUTCOMES OF TORIC AND MULTIFOCAL INTRAOCULAR LENS (IOL) IMPLANT PROCEDURES PERFORMED BY THE RESIDENT SURGEONS. FOR THIS PT, THE INVESTIGATOR REPORTED THAT THE IOL ROTATED SEVEN DEGREES AND THE PT HAD RESIDUAL CYLINDER FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. ADD'L INFO WAS REC'D FROM THE CORRESPONDING AUTHOR WHO INDICATED THAT THERE WAS NO TREATMENT FOR THIS PT AND THE EVENT CONTINUES. THERE ARE NINE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS IF FOR THIRD PT, LEFT EYE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other DUOVISC| MONARCH HANDPIECE| AND CARTRIDGE