BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 1920115 · Received December 3, 2010

    Report

    Report Number
    1119421-2010-01342
    Event Type
    Injury
    Date Received
    December 3, 2010
    Date of Event
    February 5, 2010
    Report Date
    November 5, 2010
    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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE DEVICE REMAINS IMPLANTED. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED ON 11/10/2010 AND 11/17/2010 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 11/15/2010. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PATIENT SEEING AN IMAGE FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE PATIENT DESCRIBED THE IMAGE AS A CENTRAL AREA OF BLUR IN THE SHAPE OF A DISTORTED "X" PATTERN THAT WAS SEEN AT ALL TIMES. THE SURGEON REPORTED THAT SHE COULD SEE SCRATCHES IN THE IOL. THE PATIENT HAD A HISTORY OF EPIRETINAL MEMBRANE, PSEUDO HOLE, HYPERTENSION, AND ATRIAL FIBRILLATION (PRE-EXISTING). THE SURGEON REPORTED THAT SHE HAD SEEN SCRATCHES IN IOL'S AND THEY HAD NEVER BEEN VISUALLY SIGNIFICANT. THE SURGEON REPORTED THAT IN ADDITION TO THE SCRATCHES ON THE IOL, SHE OBSERVED POSTERIOR CAPSULE OPACIFICATION AND PERFORMED A YAG LASER PROCEDURE. THERE WAS NO CHANGE IN THE PATIENT'S VISUAL DISTURBANCE FOLLOWING THE YAG LASER PROCEDURE. SHE REFERRED THE PATIENT TO ANOTHER SURGEON. THIS SURGEON PERFORMED AN OPTICAL COHERENCE TOMOGRAPHY (OCT) AND FELT THE PATIENT'S SYMPTOMS WERE RELATED TO CYSTOID MACULAR EDEMA (CME) AND MACULAR CHANGES. THE PATIENT WAS THEN REFERRED TO A RETINAL SPECIALIST WHO PERFORMED AN EPIRETINAL MEMBRANE PEEL. THERE WAS NO IMPROVEMENT IN THE PATIENT'S VISUAL DISTURBANCE. IN A FOLLOW UP, THE SURGEON REPORTED THE EVENT CONTINUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN6AT3 10946783

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention VISCOELASTIC| MONARCH DELIVERY SYSTEM