BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF IQ TORIC SINGLEPIECE IOL

    MDR report key: 11809900 · Received May 11, 2021

    Report

    Report Number
    9612169-2021-00118
    Event Type
    Malfunction
    Date Received
    May 11, 2021
    Report Date
    October 18, 2021
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    MJP
    UDI-DI
    00380652250511
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT EVALUATION: THE PRODUCT WAS RETURNED FOR ANALYSIS. AND THE REPORTED DAMAGE WAS OBSERVED. ADDITIONAL OBSERVATIONS WERE AS FOLLOWS: IOL RETURNED POSTERIOR SURFACE UP INSTEAD OF ANTERIOR SURFACE UP IN THE IOL CASE. SOLUTION IS DRIED ON BOTH SURFACES OF THE OPTIC AND HAPTICS. BOTH HAPTICS ARE INTACT. THE OPTIC IS NICKED/CHIPPED AND SCRATCHED/MARKED-REJECTABLE. WE ARE UNABLE TO DETERMINE, THE ROOT CAUSE FOR THE REPORTED COMPLAINT "DEFECTED LENS". THE RETURNED IOL SHOWS EVIDENCE OF POSSIBLE HANDLING BY THE CUSTOMER, DUE TO THE PRESENCE OF SOLUTION DRIED ON BOTH SURFACES OF THE OPTIC AND HAPTICS. IN ADDITION TO THIS, ALL IOLS ARE 100% COSMETICALLY INSPECTED, AS PER APPROVED MANUFACTURING PROCEDURES. AND THE OBSERVED, LENS DAMAGE WOULD NOT MEET OUR CURRENT RELEASE CRITERIA. BASED ON THESE INVESTIGATION FINDINGS, WE ARE UNABLE TO VERIFY, IF THE IOL CONTRIBUTED TO THE EVENT. 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. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A FACILITY REPRESENTATIVE REPORTED A "DEFECTED LENS." THE REPORTING FACILITY DECLINED TO PROVIDE FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705592 ACRYSOF IQ TORIC SINGLEPIECE IOL LENS, INTRAOCULAR, TORIC OPTICS MJP ALCON LABORATORIES IRELAND LTD. SN6AT4 21258381 00380652250511

    Patients

    Seq Age Sex Outcome Treatment
    1