BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ NATURAL SINGLEPIECE IOL

    MDR report key: 4995219 · Received August 12, 2015

    Report

    Report Number
    9612169-2015-00573
    Event Type
    Injury
    Date Received
    August 12, 2015
    Date of Event
    December 13, 2013
    Report Date
    October 22, 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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS RETURNED FOR ANALYSIS AND DAMAGE WAS OBSERVED TO THE LENS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. ADDITIONAL OBSERVATIONS WERE AS FOLLOWS; LENS RETURNED POSITIONED INCORRECTLY IN THE LENS CASE. THE LENS IS IMMERSED IN BLOOD AND SOLUTION. ONE HAPTIC IS BENT/DEFORMED AND ADHERED TO THE OPTIC EDGE WITH SOLUTION. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. 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. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION BY PHONE AND FAX. A COMPLETED QUESTIONNAIRE WAS NOT RECEIVED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL WAS NOT IMPLANTED DUE TO THE CAPSULE OPENED ON INSERTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527956 ACRYSOF IQ NATURAL SINGLEPIECE IOL INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. SN60WF 21086385

    Patients

    Seq Age Sex Outcome Treatment
    1 Other