BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 17378752 · Received July 24, 2023

    Report

    Report Number
    2023826-2023-03108
    Event Type
    Injury
    Date Received
    July 24, 2023
    Report Date
    July 11, 2023
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A2: UNK A3: UNK A4: UNK A5: UNK A6: UNK. B3: UNK. D2: COMMON DEVICE NAME: UNK. D4: EXPIRATION DATE UNK. D6A: UNK. D6B: UNK. H4: UNK H6: HEALTH EFFECT IMPACT CODE: 4644 - TOPICAL ANTIHYPERTENSIVES. CLAIM # (B)(4).

    Description of Event or Problem · 0

    A COPY OF A RETROSPECTIVE, OBSERVATIONAL STUDY WAS FOUND BY STAAR SURGICAL COMPANY, DATED (B)(6) 2023. THE STUDY WAS IN REGARD TO "REFRACTIVE OUTCOMES OF POSTERIOR CHAMBER PHAKIC (SPHERIC AND TORIC IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS IMPLANTATION WITH A CENTRAL PORT DESIGN." A TOTAL OF 254 EYES OF 134 PATIENTS UNDERWENT ICL V4C MODEL AND TORIC ICL V4C MODEL IMPLANTATION. COMPLICATION RATE OF 12.99% BEING ELEVATION OF INTRAOCULAR PRESSURE (IOP) THE MOST COMMON OBSERVED IN NINETEEN EYES, ALL OF WHICH RESPONDED WELL TO TOPICAL ANTIHYPERTENSIVES. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599366 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention