BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ RESTOR SINGLEPIECE IOL

    MDR report key: 5489243 · Received March 9, 2016

    Report

    Report Number
    1119421-2016-00424
    Event Type
    Injury
    Date Received
    March 9, 2016
    Report Date
    June 2, 2016
    Manufacturer
    ALCON RESEARCH, LTD. - HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE LENS REMAINS IMPLANTED. PRODUCT HISTORY AND BATCH RECORDS WERE REVIEWED AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE HAS NOT BEEN IDENTIFIED. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION BY PHONE AND FAX. A COMPLETED QUESTIONNAIRE WAS NOT RECEIVED. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: MENTOR ACTION WAS TAKEN BY PHONE CALL PLACED TO THE DOCTOR. IT WAS EXPLAINED THAT THIS CLINICAL SITUATION (EXCELLENT DISTANCE VISION BUT POOR NEAR VISION) IS USUALLY CAUSED BY A PATIENT THAT HAS A RESTING PUPIL THAT IS LARGER THAN THE CENTRAL APODIZED DIFFRACTIVE OPTIC OF 3.6 MM. IN THESE INSTANCES WHEN THEY GO TO READ, THE ¿WISHBONE¿ ENERGY CURVE DISTRIBUTION OF THE IOL SHIFTS THE INCOMING LIGHT TO THE DISTANCE IMAGE AND THIS IS WHY THE NEAR VISION IS TYPICALLY POOR. ALMOST ALL THESE PATIENTS IMPROVE WITH LOW-DOSE PILOCARPINE AS THE PUPILLARY CONSTRICTION INCREASES DEPTH OF FOCUS AND ALSO SHIFTS THE ENERGY DISTRIBUTION CURVE TO A POINT WHERE MORE LIGHT IS GOING TOWARD THE NEAR IMAGE. THEY USUALLY WILL USE THE PILO FOR 12 WEEKS AND CAN DISCONTINUE IT AFTER THAT POINT.

    Description of Event or Problem · 1

    A SURGEON REPORTED A PATIENT BEING UNABLE TO READ AT NEAR FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE. THE PATIENT HAS GOOD DISTANCE VISION, (20/20) BUT CANNOT READ AT NEAR EVEN WITH CORRECTIVE LENSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144461 ACRYSOF IQ RESTOR SINGLEPIECE IOL LENS, MULTIFOCAL INTRAOCULAR MFK ALCON RESEARCH, LTD. - HUNTINGTON SN6AD1 12320924

    Patients

    Seq Age Sex Outcome Treatment
    1 Other PROPARACAINE