BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 2792221 · Received October 12, 2012

    Report

    Report Number
    1119421-2012-01281
    Event Type
    Injury
    Date Received
    October 12, 2012
    Date of Event
    July 23, 2012
    Report Date
    September 14, 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFO. A COMPLETED QUESTIONNAIRE AND MEDICAL RECORDS WERE RECEIVED ON 09/25/2012. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PT WITH AN UNEXPECTED POSTOPERATIVE REFRACTION FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. MEDICAL RECORDS WERE RECEIVED AND REVIEWED. ACCORDING TO THE MEDICAL RECORDS, THE PT PRESENTED WITH A HISTORY OF DIABETES, HYPERTENSION, ARTHRITIS AND BELL'S PALSY ON THE LEFT SIDE (THIRTY YRS PRIOR TO THE EVENT), VITREAL FLOATERS IN BOTH EYES AND DRY EYES. THE PT REPORTED NEEDING INCREASED LIGHT TO READ, GLARE AND HALOS. FOLLOWING THE IOL IMPLANT PROCEDURE, THE PT REPORTED A FOREIGN BODY SENSATION AND SEEING DOUBLE APPROXIMATELY ONE WEEK FOLLOWING THE PROCEDURE. THE PT WAS INSTRUCTED TO USE ARTIFICIAL TEARS AND OINTMENT (AT NIGHT). AT THE THREE WEEK POSTOPERATIVE VISIT, THE PT REPORTED SHE HAD A "FILM" OVER HER EYE. HER UNCORRECTED VISUAL ACUITY HAD DECREASED FROM 20/40 TO 20/60. UPON EXAM, THE SURGEON NOTED THE IOL WAS AT 105 DEGREES, NOT 90 DEGREES AS IT HAD BEEN PLACED. OVER THE NEXT SEVERAL WEEKS, THE PT'S VISUAL ACUITY REMAINED STABLE, BUT DID NOT IMPROVE. AT THE SIX WEEK POSTOPERATIVE VISIT, THE PT REPORTED "A HALF MOON SHADOW" INTERMITTENTLY IN HER PERIPHERAL VISION. THE PT WAS REFERRED FOR A SECOND OPINION. THIS SURGEON REPORTED THE "BLACK VS SHINY SILVER IN THE TEMPORAL FIELD" MIGHT BE DUE TO A POSTERIOR CAPSULE WRINKLE VS THE ROTATED IOL. HIS RECOMMENDATION WAS TO TRY ROTATING THE IOL IF NOT AT THE INTENDED AXIS, LIMBAL RELAXING INCISION OR CORNEAL REFRACTIVE SURGERY TO TREAT THE RESIDUAL ASTIGMATISM. IN A F/U WITH THE SURGEON REPORTED IT IS UNK IF THE LENS CAUSED OR CONTRIBUTED TO THE EVENT. THE EVENT CONTINUES. THE SURGEON IS CONSIDERING EITHER LASIK, IOL ROTATION OR A LENS EXCHANGE PROCEDURE. NO F/U PROCEDURES HAVE BEEN PERFORMED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN6AT4 12071779

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention PATANOL EYE DROPS| PRED FORTE| BROMDAY| MONARCH D CARTRIDGE| ZYMAXID| PROVISC| MONARCH II HANDPIECE| VISCOAT