BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 3176906 · Received June 12, 2013

    Report

    Report Number
    1119421-2013-00651
    Event Type
    Injury
    Date Received
    June 12, 2013
    Date of Event
    January 1, 2013
    Report Date
    May 17, 2013
    Manufacturer
    ALCON MANUFACTURING, LTD.
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 MANUFACTURING DOCUMENTATION. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. NOT ENOUGH INFORMATION WAS PROVIDED FROM THE ACCOUNT FOR FURTHER INVESTIGATION. COSTANTINOU, MARIOS, JHANJI, VISHAL, JING, XIE, LAMOREUX, ECOSSE L., BOFFA, UMBERTO, TAYLOR, HUGH R., VAJPAYEE, RASIK B., AND FRANZCO, M.S..A RANDOMIZED, SINGLE-CENTER STUDY OF EQUIVALENCE OF 2 INTRAOCULAR LENSES USED IN CATARACT SURGERY. OPHTHALMOLOGY; 2013; 120:482-488. (B)(4).

    Description of Event or Problem · 1

    THE AUTHOR OF A LITERATURE ARTICLE REPORTED THAT A RUPTURED POSTERIOR CAPSULE OCCURRED IN ONE OF THE STUDY PATIENTS. THE IOL WAS ULTIMATELY IMPLANTED IN THE ANTERIOR CHAMBER. THE PURPOSE OF THE STUDY WAS TO COMPARE THE OUTCOMES OF TWO INTRAOCULAR LENSES (IOLS) TO TREAT AGE-RELATED CATARACTS. THERE WAS NO SIGNIFICANT DIFFERENCE BETWEEN THE TWO GROUPS WITH REGARD TO VISUAL FUNCTIONING OR THE INCIDENCE OF ADVERSE SURGICAL EVENTS. THE POSTOPERATIVE COURSE WAS UNEVENTFUL IN ALL THE PATIENTS IN BOTH GROUPS AT THE END OF 1, 6, AND 12 MONTHS. NO FURTHER INFORMATION IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265686 ACRYSOF INTRAOCULAR LENS HQL ALCON MANUFACTURING, LTD. SA60AT UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention