BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 19249803 · Received May 6, 2024

    Report

    Report Number
    2023826-2024-02089
    Event Type
    Injury
    Date Received
    May 6, 2024
    Report Date
    April 7, 2024
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: B5-A RETROSPECTIVE STUDY OF PHAKIC- IOL SIZING USING THE OCOS NOMOGRAM WITH OPTIMISED WHITE TO WHITE MEASUREMENTS: 12-MONTH CLINICAL RESULTS THE PURPOSE OF THIS RETROSPECTIVE ASSESSMENT WAS TO EVALUATE THE OCOS CALCULATOR WITH OPTIMIZED WTW AT SIZING ICL. EVALUATE VAULT UP TO 1 YEAR, OBSERVE AND RECORD COMPLICATIONS OF +/- ICL EXPLANTATIONS. 240 EYES OF 124 PATIENTS WERE IMPLANTED EVO ICL OVER A 5-YEAR PERIOD. PRE-OP ICL SIZING WAS CALCULATED USING AN OCOS NOMOGRAM WITH WTWT OPTIMIZING BY SUBTRACTING 0.4MM AS PER MANUFACTURER'S ADVICE. PATIENTS WERE FOLLOWED UP AT 2 WEEKS, 3 MONTHS AND 1 YEAR TO MEASURE THE VAULT HEIGHT USING OCT SCANS. ICL SIZING DEEMED "IDEAL" IF THE VAULT WAS RECORDED BETWEEN 250-750MM. THE RESULTS WERE AT 3 MONTHS 69% OF LENSES WERE FOUND TO BE WITHIN RANGE WITH 12% UNDERSIZED AND 19% OVER SIZED. AT 1 YEAR 62% OF LENSES WERE FOUND TO BE IN RANGE WITH 21% UNDERSIZED AND 17% OVERSIZED. COMPLICATIONS REPORTED ARE 1 HYPEROPIC SURPRISE AND UNDERWENT ICL EXPLANT WITH REFRACTIVE LENS EXCHANGE. ONE PATIENT HAD POST OP IOP OF 28 AT 2 WEEKS BUT NOT DUE TO EXCESSIVE VAULT AND RESOLVED WITH 1 WEEK TOPICAL THERAPY. IN CONCLUSION: OCOS CORRECTLY SIZES 69% OF LENSES AT 3 MONTHS WITH MOST ERRORS BEING OVERSIZED. AT 1-YEAR DECREASES TO 62% SUGGESTING THAT AS VAULT HEIGHT DECREASES OVER TIME, OVERSIZING IS LESS OF AN ISSUE. NO COMPLICATIONS DUE TO VAULT HEIGHT. CLAIM# (B)(4).

    Description of Event or Problem · 0

    A RETROSPECTIVE STUDY OF PHAKIC- IOL SIZING USING THE OCOS NOMOGRAM WITH OPTIMISED WHITE TO WHITE MEASUREMENTS: 12-MONTH CLINICAL RESULTS THE PURPOSE OF THIS RETROSPECTIVE ASSESSMENT WAS TO EVALUATE THE OCOS CALCULATOR WITH OPTIMIZED WTW AT SIZING ICL. EVALUATE VAULT UP TO 1 YEAR, OBSERVE AND RECORD COMPLICATIONS OF +/- ICL EXPLANTATIONS. 240 EYES OF 1245 PATIENTS WERE IMPLANTED EVO ICL OVER A 5-YEAR PERIOD. PRE-OP ICL SIZING WAS CALCULATED USING AN OCOS NOMOGRAM WITH WTWT OPTIMIZING BY SUBTRACTING 0.4MM AS PER MANUFACTURER'S ADVICE. PATIENTS WERE FOLLOWED UP AT 2 WEEKS, 3 MONTHS AND 1 YEAR TO MEASURE THE VAULT HEIGHT USING OCT SCANS. ICL SIZING DEEMED "IDEAL" IF THE VAULT WAS RECORDED BETWEEN 250-750MM. THE RESULTS WERE AT 3 MONTHS 69% OF LENSES WERE FOUND TO BE WITHIN RANGE WITH 12% UNDERSIZED AND 19% OVER SIZED. AT 1 YEAR 62% OF LENSES WERE FOUND TO BE IN RANGE WITH 21% UNDERSIZED AND 17% OVERSIZED. COMPLICATIONS REPORTED ARE 1 HYPEROPIC SURPRISE AND UNDERWENT ICL EXPLANT WITH REFRACTIVE LENS EXCHANGE. ONE PATIENT HAD POST OP IOP OF 28 AT 2 WEEKS BUT NOT DUE TO EXCESSIVE VAULT AND RESOLVED WITH 1 WEEK TOPICAL THERAPY. IN CONCLUSION: OCOS CORRECTLY SIZES 69% OF LENSES AT 3 MONTHS WITH MOST ERRORS BEING OVERSIZED. AT 1-YEAR DECREASES TO 62% SUGGESTING THAT AS VAULT HEIGHT DECREASES OVER TIME, OVERSIZING IS LESS OF AN ISSUE. NO COMPLICATIONS DUE TO VAULT HEIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777281 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention