BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAAR ICL CALCULATION SOFTWARE

    MDR report key: 25050022 · Received April 30, 2026

    Report

    Report Number
    2023826-2026-00744
    Event Type
    Malfunction
    Date Received
    April 30, 2026
    Report Date
    April 30, 2026
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    UDI-DI
    00840311346288
    PMA / PMN Number
    P030016/S001
    Removal / Correction Number
    9614429/04302026/C/001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IDENTIFIED A CODING ERROR WITHIN THE STELLA 2.0 PROGRAM SOFTWARE; WHEN A CUSTOMER HAS MULTIPLE TORIC LENS LINE ITEMS IN STELLA (MULTIPLE TORIC LENS RESERVATIONS FOR THE SAME EYE) AND AN IOD IS GENERATED FROM THE PATIENT'S LIST VIEW PAGE, ORDER CONFIRMATION OR SHOPPING CART, THE SYSTEM MAY INCORRECTLY DISPLAY THE SAME PLACEMENT AXIS FOR ALL RESERVED TORIC LENSES INSTEAD OF THE CORRECT PLACEMENT AXIS ASSOCIATED WITH EACH INDIVIDUAL LENS LINE ITEM. ONLY THE IMPLANT ORIENTATION DIAGRAM (IOD) PRINTED USING STELLA 2.0 BETWEEN (B)(6) AND (B)(6) 2026, AND NOT THE LENS ITSELF, IS AFFECTED BY THIS ISSUE. D2 - THE PRODUCT CODE "MTA" IS ENTERED TO SATISFY MANDATORY FIELD REQUIREMENTS, AS THE DEVICE SOFTWARE IS NOT CURRENTLY CLASSIFIED AND DOES NOT HAVE AN ASSIGNED FDA PRODUCT CODE. G4-PMA/510(K): P030016/S001/A016. CLAIM #(B)(4).

    Description of Event or Problem · 0

    THE REPORTER INDICATED THAT THE STELLA 2.0 IMPLANT ORIENTATION DIAGRAM (IOD) SOFTWARE GENERATED AN INCORRECT LENS ORIENTATION DIAGRAM DURING LENS SELECTION. THE REPORTER NOTED THAT ADVERSE EVENTS WERE ASSOCIATED WITH THE EVENT; HOWEVER, IT IS UNCLEAR WHETHER AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION HAS OCCURRED. A REFRACTIVE ERROR IS POSSIBLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN RECEIVED. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED IF FURTHER DETAILS BECOME AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479841 STAAR ICL CALCULATION SOFTWARE ICL CALCULATION SOFTWARE MTA STAAR SURGICAL COMPANY N/A N/A 00840311346288

    Patients

    Seq Age Sex Outcome Treatment
    1