BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 15848644 · Received November 22, 2022

    Report

    Report Number
    2023826-2022-04264
    Event Type
    Malfunction
    Date Received
    November 22, 2022
    Report Date
    October 26, 2022
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    QCB
    PMA / PMN Number
    P030016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B5: THE REPORTER INDICATED THAT A 13.2MM VTICMO 13.2 IMPLANTABLE COLLAMER LENS OF DIOPTER -9.0/5.5/111 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED IN THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2022 AS A REPLACEMENT LENS TO RESOLVE LOW VAULT. LOW VAULT IS STILL BEING OBSERVED. THE LENS REMAINS IMPLANTED. THE PROBLEM WAS NOT RESOLVED. REPORTEDLY "THE DOCTOR BELIEVED THAT AFTER REPLACING THE CRYSTAL, THE ARCH HEIGHT WAS NOT IDEAL, DID NOT SOLVE THE PROBLEM, AND CONTINUED CLINICAL OBSERVATION". CLAIM#: (B)(4).

    Description of Event or Problem · 0

    THE REPORTER INDICATED THAT A 13.2MM VTICMO 13.2 IMPLANTABLE COLLAMER LENS OF -9.0/5.5/111 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED AS AN EXCHANGE LENS IN THE PATIENTS RIGHT EYE (OD) ON 31-JUL-2022 TO RESOLVE LOW VAULT. LOW VAULT IS STILL BEING OBSERVED. THE LENS REMAINS IMPLANTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.SEE MFR # 2023826-2022-042643 FOR INITIAL LENS IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308650 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC TORIC INTRAOCULAR LENS QCB STAAR SURGICAL COMPANY VTICMO 13.2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Female