BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ NATURAL SINGLEPIECE IOL

    MDR report key: 5704472 · Received June 7, 2016

    Report

    Report Number
    1119421-2016-00850
    Event Type
    Injury
    Date Received
    June 7, 2016
    Date of Event
    April 18, 2016
    Report Date
    August 25, 2016
    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
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE LENS REMAINS IMPLANTED. THE INTRAOCULAR LENS (IOL) PRODUCT HISTORY RECORDS WERE REVIEWED AND DOCUMENTATION INDICATES THE PRODUCT MET RELEASE CRITERIA. CARTRIDGE PRODUCT HISTORY RECORD COULD NOT BE REVIEWED BECAUSE FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ROOT CAUSE HAS NOT BEEN IDENTIFIED. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. FOUR PHOTOS WERE PROVIDED AND REVIEWED BY A COMPANY PHYSICIAN. THREE OF OCULAR FUNDUS AND ONE OF A DILATED PUPIL WITH AN IMPLANTED IOL. A WHITE OPACITY IS OBSERVED INFERIORLY WITH A WELL DEFINED UNIFORM EDGE. NEITHER THE ORIGIN NOR THE EXACT LOCATION OF THE OPACITY CAN BE DETERMINED. (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: ADDITIONAL INFORMATION WAS PROVIDED, WHICH INDICATED A QUALIFIED CARTRIDGE WITH A QUALIFIED INJECTOR; HOWEVER, WITH AN UNQUALIFIED VISCOELASTIC. THIS LENS/CARTRIDGE/INJECTOR COMBINATION IS ONLY QUALIFIED FOR USE WITH SPECIFIC VISCOELASTICS. MEDICAL REVIEW OF THE 4 PHOTOS WERE PROVIDED, 3 OF OCULAR FUNDUS AND ONE OF A DILATED PUPIL WITH AN IMPLANTED IOL. A WHITE OPACITY IS OBSERVED INFERIORLY WITH A WELL DEFINED UNIFORM EDGE. NEITHER THE ORIGIN NOR THE EXACT LOCATION OF THE OPACITY CAN BE DETERMINED. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. DUE TO VARYING MATERIAL PROPERTIES, THE USE OF NON-QUALIFIED VISCOELASTIC MAY RESULT IN LENS DELIVERY DIFFICULTIES OR PRODUCT DAMAGE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AN OPHTHALMOLOGIST REPORTED SUB SURFACE NANO-GLISTENINGS (SSNG) OF A LENS FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE. ADDITIONAL INFORMATION WAS PROVIDED THAT THE PATIENT HAS BEEN COMPLAINING OF A DIFFICULTY IN SEEING. PRODUCT SAMPLE IS NOT AVAILABLE FOR RETURN AS IT REMAINS IMPLANTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS PROVIDED BY THE SURGEON, WHO REPORTED THAT APPROXIMATELY SEVEN YEARS FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THERE WAS FUNDUS CLOUDINESS CONFIRMED COMPARED TO AN FUNDUSCOPY EXAMINATION RESULTS FROM TWO WEEKS PRIOR. THERE WAS IOL CLOUDINESS CONFIRMED UNDER MYDRIASIS. THE FUNDUS IMAGE APPEARED FUZZIER AND IT WAS DETERMINED THAT THIS WAS CAUSED BY A RAPID CLOUDING OF THE IOL RESULTING IN VISUAL IMPAIRMENT. THE PATIENT WAS ALSO DIAGNOSED WITH AN "AFTER CATARACT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359129 ACRYSOF IQ NATURAL SINGLEPIECE IOL INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. - HUNTINGTON SN60WF 10842468

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other