BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF SINGLEPIECE IOL

    MDR report key: 5003381 · Received August 14, 2015

    Report

    Report Number
    1119421-2015-06041
    Event Type
    Injury
    Date Received
    August 14, 2015
    Date of Event
    June 12, 2015
    Report Date
    October 9, 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
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN INCORPORATED: EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THE ROOT CAUSE FOR THE REPORTED COMPLAINT COULD NOT BE DETERMINED. BASED ON THE RESULTS FROM THE PRODUCT AND BATCH HISTORY RECORD, THE PRODUCT MET RELEASE CRITERIA. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    DOCTOR OF OPHTHALMOLOGY REPORTED AN UNEXPECTED POSTOPERATIVE REFRACTION AFTER A CATARACT SURGERY. THE PATIENT WAS ABLE TO ACCOMMODATE TO THE REFRACTIVE DIFFERENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE. THIS IS ONE OF TWO REPORTS BEING FILED FOR THIS PATIENT. THIS REPORT IS FOR PATIENT'S LEFT EYE (OS).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE SURGEON WHO REPORTED THAT POSTOPERATIVE REFRACTIONS WERE NOT IN ACCORDANCE WITH THE EXPECTATIONS. IN SURGEON'S OPINION THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT. NO PATIENT HOSPITALIZATION, THERAPIES OR UNPLANNED SURGICAL INTERVENTION WERE REQUIRED TO TREAT THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540178 ACRYSOF SINGLEPIECE IOL INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. SN60AT 21125521

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other