BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAAR ICL CALCULATION SOFTWARE

    MDR report key: 25212446 · Received May 19, 2026

    Report

    Report Number
    2023826-2026-00872
    Event Type
    Malfunction
    Date Received
    May 19, 2026
    Report Date
    May 18, 2026
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    UDI-DI
    00840311346288
    PMA / PMN Number
    P030016/S001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IDENTIFIED AN ISSUE WITHIN THE STELLA 2.0 PROGRAM SOFTWARE: THE IOD FOR LEGACY ORDERS DISPLAYS THE WRONG EXP REFRACTION VALUE. IT IS DISPLAYING THE TARGET LENS VALUE INSTEAD OF THE RESERVED LENS VALUES. 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 #435703.

    Description of Event or Problem · 0

    THE REPORTER INDICATED THAT THE STELLA 2.0 IMPLANT ORIENTATION DIAGRAM (IOD) SOFTWARE GENERATED AN OUTPUT IN WHICH THE EXPECTED SEQ (SPHERICAL EQUIVALENT) AND EXPECTED REFRACTION VALUES DID NOT ALIGN. SPECIFICALLY, THE EXPECTED REFRACTION DISPLAYED ON THE IOD CORRESPONDED TO THE TARGET LENS RATHER THAN THE SELECTED/ORDERED LENS. THE ISSUE WAS IDENTIFIED BY THE SURGEON PRIOR TO LENS IMPLANTATION. THERE WAS NO REPORTED PATIENT HARM ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602830 STAAR ICL CALCULATION SOFTWARE ICL CALCULATION SOFTWARE MTA STAAR SURGICAL COMPANY N/A N/A 00840311346288

    Patients

    Seq Age Sex Outcome Treatment
    1