BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ NATURAL SINGLEPIECE IOL

    MDR report key: 4850758 · Received June 17, 2015

    Report

    Report Number
    1119421-2015-05605
    Event Type
    Injury
    Date Received
    June 17, 2015
    Date of Event
    December 19, 2014
    Report Date
    September 8, 2015
    Manufacturer
    ALCON RESEARCH, LTD. - HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION PROVIDED: EVALUATION SUMMARY: 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 FOR THIS LOT.

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. COMPLAINT HISTORY AND PRODUCT HISTORY RECORD COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A VALID LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ROOT CAUSE HAS NOT BEEN IDENTIFIED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. INITIAL REPORTER. ZIP CODE IS NOT INDICATED AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    A DOCTOR OF OPHTHALMOLOGY REPORTED A BREAK IN A POSTERIOR CAPSULE DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE. IT APPEARED THAT THE INJECTION OF THE IOL BROKE THE CAPSULE; HOWEVER, VISUALIZATION WAS POOR DUE TO CORNEAL OPACIFICATION (DYSTROPHY). THE IOL WAS THEN REMOVED AND REPLACED WITH ANOTHER LENS DURING THE INITIAL PROCEDURE; HOWEVER, THERE WAS NOT ENOUGH SUPPORT FOR THIS LENS AND IT WAS ALSO REMOVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE SURGEON HAD PERFORMED AN ENDOTHELIAL TRANSPLANT PRIOR TO IMPLANTING THE INTRAOCULAR LENS. THE PATIENT IS RECOVERING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395105 ACRYSOF IQ NATURAL SINGLEPIECE IOL INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. - HUNTINGTON SN60WF 12300043

    Patients

    Seq Age Sex Outcome Treatment
    1 Other