BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ NATURAL SINGLEPIECE IOL

    MDR report key: 4995211 · Received August 12, 2015

    Report

    Report Number
    9612169-2015-00571
    Event Type
    Injury
    Date Received
    August 12, 2015
    Date of Event
    July 13, 2015
    Report Date
    November 2, 2015
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS RETURNED FOR ANALYSIS AND DAMAGE WAS OBSERVED TO THE LENS. ADDITIONAL OBSERVATIONS WERE AS FOLLOWS; LENS RETURNED POSITIONED INCORRECTLY IN THE LENS CASE. THE LENS IS IMMERSED IN BLOOD AND SOLUTION. ONE HAPTIC IS BROKEN/TORN AND NOT RETURNED. THE ROOT CAUSE FOR THE REPORTED COMPLAINT COULD NOT BE DETERMINED. NO MALFUNCTION HAS BEEN INDICATED AGAINST THE PRODUCT. (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS RETURNED FOR ANALYSIS. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. 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 HAS BEEN REQUESTED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE A SURGEON REPORTED THE PATIENTS CAPSULE RUPTURED. THE LENS WAS THEN REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531959 ACRYSOF IQ NATURAL SINGLEPIECE IOL INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. SN60WF 21120205

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other