BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF TORIC

    MDR report key: 3784781 · Received February 18, 2014

    Report

    Report Number
    1119421-2014-00110
    Event Type
    Malfunction
    Date Received
    February 18, 2014
    Date of Event
    December 1, 2013
    Report Date
    January 17, 2014
    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
    CH
    Reporter Occupation
    NOT APPLICABLE

    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 FOR THE REPORTED COMPLAINT. THE COMPLAINT WAS OPENED FROM A LITERATURE REPORT "COMPARATIVE STUDY ON POSTOPERATIVE VISUAL QUALITY AFTER IMPLANTATION OF SPHERICAL AND ASPHERIC TORIC IOL. NO ENOUGH INFO WAS PROVIDED FROM THE ACCOUNT FOR FURTHER INVESTIGATION. PEI-LI H. COMPARATIVE STUDY ON POSTOPERATIVE VISUAL QUALITY AFTER IMPLANTATION OF SPHERICAL AND ASPHERIC TORIC IOL. REC ADV OPHTHALMOL, 2013, 33 (12): 1136-1139. ADD'L INFO WAS REQUESTED. (B)(4).

    Description of Event or Problem · 1

    IN A JOURNAL ARTICLE, THE AUTHORS REPORTED A COMPARISON OF THE VISUAL QUALITY AFTER SPHERICAL AND ASPHERIC ASTIGMATISM TYPE OF INTRAOCULAR LENS (IOL) IMPLANTATION. A TOTAL OF 52 PTS (55 EYES) WITH CATARACT WERE DIVIDED INTO TWO GROUPS: THE OBSERVATION GROUP OF 21 PTS (23 EYES) REC'D THE ASPHERIC IOL IMPLANTATION, AND THE CONTROL GROUP OF 31 CASES (32 EYES) REC'D THE SPHERICAL IMPLANTATION. IN THIS STUDY, POSTOPERATIVE 3-MONTH RESIDUAL ASTIGMATISM WAS DECREASED SIGNIFICANTLY COMPARED WITH THE PREOPERATIVE RESIDUAL ASTIGMATISM, INDICATING THAT ASPHERIC IOL CAN EFFECTIVELY CORRECT CORNEAL ASTIGMATISM. NO SIGNIFICANT DIFFERENCE IN POSTOPERATIVE RESIDUAL ASTIGMATISM AND EXPECTED RESIDUAL ASTIGMATISM, INDICATING THAT THE IOL HAS STRONG PREDICTABILITY. THE AUTHORS REPORTED THAT AFTER THE INTRAOCULAR LENSES (IOL) WERE IMPLANTED, THERE WAS MINIMAL IOL ROTATION FOR BOTH GROUPS. ADD'L INFO HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS ASSOCIATED WITH THE INTRAOCULAR LENSES IMPLANTED IN THE CONTROL GROUP; A SEPARATE MEDICAL DEVICE REPORT WILL BE FILED ASSOCIATED WITH THE INTRAOCULAR LENSES IMPLANTED IN THE OBSERVATION GROUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100955 ACRYSOF TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 BENOXIL| TOBRADEX| TROPICAMIDE