BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF IQ ASPHERIC IOL WITH THE ULTRASERT PRE-LOADED DELIVERY SYSTEM

    MDR report key: 12051402 · Received June 23, 2021

    Report

    Report Number
    9612169-2021-00138
    Event Type
    Malfunction
    Date Received
    June 23, 2021
    Date of Event
    May 28, 2021
    Report Date
    September 14, 2021
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    HQL
    UDI-DI
    00380652394802
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION PROVIDED IN H6. (PREVIOUSLY REPORTED DEVICE CODES 2524 SUBMITTED IN ERROR). THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE ROOT CAUSE FOR THE REPORTED COMPLAINT COULD NOT BE DETERMINED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. ALL PRODUCT AND BATCH HISTORY RECORDS ARE QUALITY REVIEWED PRIOR TO PRODUCT RELEASE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    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 ONE OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE AS THE SURGEON INJECTED THE LENS, THE PART OF THE OPTIC WITH TRAILING HAPTIC ATTACHED SEEMED TO NOT RELEASE FROM THE BLUE PLUNGER. AS HE WITHDREW THE PLUNGER IT BROKE OFF THE OPTIC AND RETURNED INTO THE INSERTER. THE BROKEN LENS WAS REMOVED FROM THE EYE, AND A SECOND LENS WAS INSERTED WITHOUT ISSUE. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    950189 ACRYSOF IQ ASPHERIC IOL WITH THE ULTRASERT PRE-LOADED DELIVERY SYSTEM INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. AU00T0 21274080 00380652394802

    Patients

    Seq Age Sex Outcome Treatment
    1 PROVISC| PROVISC OPHTHALMIC VISCOSURGICAL DEVICE| PROVISC