BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2705828 · Received August 17, 2012

    Report

    Report Number
    1119421-2012-01029
    Event Type
    Injury
    Date Received
    August 17, 2012
    Date of Event
    May 5, 2009
    Report Date
    July 17, 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
    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 AN UNEXPECTED POSTOPERATIVE OUTCOME WITH RESIDUAL ASTIGMATISM 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. HE ALSO DOES NOT FEEL THE IOL CAUSED OR CONTRIBUTED TO THE EVENT. THERE ARE NINE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS IS FOR THE SIXTH PT, RIGHT EYE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other MONARCH HANDPIECE| DUOVISC| AND CARTRIDGE