BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAAR ICL CALCULATION SOFTWARE

    MDR report key: 25249974 · Received May 21, 2026

    Report

    Report Number
    2023826-2026-00890
    Event Type
    Malfunction
    Date Received
    May 21, 2026
    Report Date
    May 21, 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
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER NARRATIVE: INVESTIGATION IDENTIFIED AN ISSUE WITHIN THE STELLA 2.0 PROGRAM SOFTWARE: WHEN GENERATING AN IOD OVERRIDE, THE EXPECTED REFRACTION (EXP REF), EXPECTED EQUIVALENCE (EXP SEQ), MODEL AND VERSION NUMBER OF THE ORIGINAL RESERVED LENS IS BEING DISPLAYED, NOT THE INFORMATION FROM THE OVERRIDE LENS. THIS IS APPARENT WHEN THE OVERRIDE LENS IS A MODEL/VERSION THAT IS COMPLETELY DIFFERENT FROM THE ORIGINAL RESERVED LENS. WHEN GENERATING AN IOD OVERRIDE, THE CORRECT SERIAL NUMBER (SN), AXIS AND ROTATION ARE DISPLAYED. 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 WHEN DUPLICATING A CALCULATION IN THE STELLA 2.0 SOFTWARE, THE EXPECTED REFRACTION AND THE EXPECTED SEQ (SPHERICAL EQUIVALENT) DISPLAYED ON THE DUPLICATED CALCULATION DID NOT MATCH THE VALUES DISPLAYED IN THE ORIGINAL CALCULATION. CAUSE OF EVENT WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409429 STAAR ICL CALCULATION SOFTWARE ICL CALCULATION SOFTWARE MTA STAAR SURGICAL COMPANY N/A N/A 00840311346288

    Patients

    Seq Age Sex Outcome Treatment
    1