BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 17610615 · Received August 24, 2023

    Report

    Report Number
    2023826-2023-03705
    Event Type
    Injury
    Date Received
    August 24, 2023
    Report Date
    August 23, 2023
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    QCB
    UDI-DI
    00841542109444
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: H6- HEALTH EFFECT - CLINICAL CODE: "1766" AND "2137" SHOULD BE ADDED. H6- HEALTH EFFECT - IMPACT CODE: "2199" SHOULD BE REMOVED. "4614 " SHOULD BE ADDED. H6- MEDICAL DEVICE PROBLEM CODE: "2993" SHOULD BE REMOVED. "1401" SHOULD BE ADDED. B5- THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM TMICL 13.2 IMPLANTABLE COLLAMER LENS OF DIOPTER -13.00/1.5/092 (SPHERE/CYLINDER/AXIS) INTO THE PATIENT'S LEFT EYE (OS). THE PATIENT EXPERIENCED AN ASC LENS OPACITY OBSERVED ON 17/MAY/2023, REFRACTIVE CHANGE OVER TIME, AND A SPHERICAL CONTACT LENS PRESCRIBED. THE LENS REMAINS IMPLANTED. STATUS OF THE EYE:" PATIENT IS TRIALING SCL (SPHERICAL CONTACT LENS) OS FOR THE REFRACTIVE SHIFT; WILL DEFER CATARACT SURGERY FOR NOW." CLAIM# (B)(4).

    Additional Manufacturer Narrative · 0

    A4 - UNK, A5 - UNK, A6 - UNK, B3 - UNK, D6A - UNK. CLAIM# (B)(4).

    Description of Event or Problem · 0

    THE REPORTER INDICATED THAT A 13.2MM, TMICL13.2, -11.0/1.0/075 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS). LENS OPACITY (CATARACT) ASC WAS OBSERVED ON (B)(6) 2023. LENS REMAINS IMPLANTED. REPORTEDLY, PATIENT IS TRAILING A SCL FOR THE REFRACTIVE SHIFT AND WILL REFER CATARACT SURGERY FOR NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56575 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC TORIC INTRAOCULAR LENS QCB STAAR SURGICAL COMPANY TMICL13.2 N/A 00841542109444

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention UNK.