BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 2867201 · Received December 7, 2012

    Report

    Report Number
    1119421-2012-01522
    Event Type
    Injury
    Date Received
    December 7, 2012
    Date of Event
    January 1, 2012
    Report Date
    November 7, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. A COMPLETE INVESTIGATION COULD NOT BE CONDUCTED DUE TO INSUFFICIENT INFORMATION. CITATION: SAMUEL MASKET. CATARACT SURGICAL PROBLEM. JOURNAL OF CATARACT AND REFRACTIVE SURGERY (2012) 38: 1868-1873. (B)(4).

    Description of Event or Problem · 1

    IN A LITERATURE ARTICLE, A SURGEON PRESENTED A CASE OF INTRAOCULAR LENS (IOL) MALPOSITION THAT CAUSED POSTOPERATIVE RECURRENT MICROHYPHEMAS AND VITREOUS HEMORRHAGES WITH INCREASING FREQUENCY. THE AFFECTED EYE ALSO HAD ANTERIOR CHAMBER INFLAMMATION, MICROHYPHEMAS WITH WHITE AND RED BLOOD CELLS, MARKED IRIS CHAFING, AND ANTERIOR AND POSTERIOR CAPSULE FIBROSIS. THE SURGEON STATED THAT THE IOL WAS NOT FULLY CONFINED IN THE CAPSULAR BAG AND THE HAPTICS WERE ASYMMETRICALLY PLACED; WHILE ONE HAPTIC WAS IN THE CILIARY SULCUS, THE OTHER HAPTIC WAS IN THE CAPSULAR BAG. THE IOL WAS ALSO NOTED TO BE TILTED ANTERIORLY, WHICH CONTRIBUTED TO SHAVING OF THE POSTERIOR IRIS. THE SURGEON REFERRED TO THIS EVENT AS POSTERIOR-UVEITIS-HYPHEMA (UGH) SYNDROME. THE ARTICLE PRESENTS VARIOUS POTENTIAL INTERVENTION TECHNIQUES, AS SUGGESTED BY MULTIPLE SURGEONS; HOWEVER, THE ARTICLE DOES NOT MENTION WHICH COURSE OF ACTION OR INTERVENTION WAS ULTIMATELY PERFORMED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON MA60MA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other ASPIRIN (LOW DOSE)