BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAAR ICL CALCULATION SOFTWARE

    MDR report key: 25234386 · Received May 20, 2026

    Report

    Report Number
    2023826-2026-00873
    Event Type
    Malfunction
    Date Received
    May 20, 2026
    Report Date
    May 20, 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
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11 - MANUFACTURER NARRATIVE: INVESTIGATION IDENTIFIED AN ISSUE WITHIN THE STELLA 2.0 PROGRAM SOFTWARE: FOR A PREVIOUSLY SAVED OCOS LEGACY RESERVATION WITH A LENS, SELECTING THE "LENSCALC" BUTTON IN STELLA 2.0 GENERATES AN IOD THAT DISPLAYS THE EXP REF AND EXP SEQ INFORMATION OF THE TARGETED LENS, RATHER THAN THE SELECTED LENS. 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
    271924 STAAR ICL CALCULATION SOFTWARE ICL CALCULATION SOFTWARE MTA STAAR SURGICAL COMPANY N/A N/A 00840311346288

    Patients

    Seq Age Sex Outcome Treatment
    1