BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF TORIC

    MDR report key: 3603829 · Received December 6, 2013

    Report

    Report Number
    1119421-2013-01190
    Event Type
    Malfunction
    Date Received
    December 6, 2013
    Report Date
    November 11, 2013
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    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. NAKANO Y, NOMOTO H, FUKUDA K, YAMAJI H, FUJITA T, INOUE Y, SHIRAGA F; J CATARACT REFRACT SURG; 39:686-693 2013 ASCRS AND ESCRS. ADDITIONAL INFORMATION IS NOT EXPECTED. (B)(4).

    Description of Event or Problem · 1

    IN A JOURNAL ARTICLE, THE AUTHORS EVALUATED THE STABILITY OF AXIS ROTATION, ASTIGMATISM CORRECTION, AND IMPROVEMENT IN UNCORRECTED DISTANCE VISUAL ACUITY UP TO SIX MONTHS POSTOPERATIVELY USING AN ASTIGMATISM CORRECTING INTRAOCULAR LENS (IOL) IN A 25-GAUGE TRANSCONJUNCTIVAL SUTURELESS VITRECTOMY COMBINED WITH CATARACT SURGERY. THE AUTHORS REPORTED OF THE NINETEEN EYES EVALUATED, NINETEEN HAD AN IOL AXIS ROTATION FOLLOWING A TORIC IOL IMPLANTATION WITH A VITRECTOMY TRIPLE PROCEDURE. THREE MONTHS POSTOPERATIVELY, THE AXIS ROTATION WAS LESS THAN 5 DEGREES IN FOURTEEN EYES, LESS THAN TEN DEGREES IN FOUR EYES. ONE PATIENT HAD A ROTATION OF MORE THAN TEN DEGREES; HOWEVER, NO INTRAOPERATIVE OR POSTOPERATIVE COMPLICATIONS OCCURRED AND THE CAUSE OF ROTATION FOR THIS PATIENT WAS UNCLEAR. NO COMPLICATIONS OCCURRED WITH ANY PATIENT DURING CATARACT SURGERY, DURING VITRECTOMY OR POSTOPERATIVELY. OVERALL, POSTOPERATIVE IOL AXIS STABILITY WAS SIMILAR TO THAT REPORTED FOR CATARACT SURGERY ALONE. ADDITIONAL INFORMATION WAS REQUESTED BUT NO FURTHER INFORMATION IS EXPECTED. THIS MEDICAL DEVICE REPORT INCLUDES ALL IOL ROTATIONS REPORTED IN THIS LITERATURE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634601 ACRYSOF TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1