BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 15830521 · Received November 19, 2022

    Report

    Report Number
    2023826-2022-03972
    Event Type
    Injury
    Date Received
    November 19, 2022
    Date of Event
    October 3, 2022
    Report Date
    October 21, 2022
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    QCB
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CLAIM # (B)(4).

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: B1: ADVERSE EVENT SHOULD BE CORRECTED TO PRODUCT PROBLEM. B2: OUTCOMES ATTRIBUTED TO ADVERSE EVENT- SHOULD BE OMITTED FOR CORRECTION. D9: DEVICE AVAILABLE FOR EVALUATION: YES; RETURN DATE: 20-DEC-2022. CLAIM#: (B)(4).

    Additional Manufacturer Narrative · 0

    H3 - DEVICE EVALUATION: THE LENS WAS RETURNED DRY IN A MICROCENTRIFUGE VIAL WITH RESIDUE/DEBRIS ON THE LENS. VISUAL INSPECTION FOUND THE HAPTIC TORN AND BENT WITH FOREIGN MATERIAL ON THE LENS, SPECIFICALLY DEBRIS THROUGHOUT THE LENS. CLAIM# (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B5: THE REPORTER INDICATED THAT A 12.6MM VTICMO12.6 IMPLANTABLE COLLAMER LENS OF -15.5/1.5/170 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) AS A REPLACEMENT LENS ON (B)(6) 2022. THE LENS WAS EXPLANTED AT AN UNKNOWN DATE. THE PROBLEM WAS NOT RESOLVED FOR THE EXCHANGE. REPORTEDLY, "VISUAL GHOSTING," AND "TAKE OUT THE CRYSTAL." CLAIM# (B)(4).

    Description of Event or Problem · 0

    THE REPORTER INDICATED THAT A 12.6MM VTICMO12.6 IMPLANTABLE COLLAMER LENS OF -15.5/1.5/170 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) AS A REPLACEMENT LENS ON (B)(6) 2022. THE PROBLEM WAS NOT RESOLVED FOR THE EXCHANGE. REPORTEDLY, "VISUAL GHOSTING," AND "TAKE OUT THE CRYSTAL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1729869 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC TORIC INTRAOCULAR LENS QCB STAAR SURGICAL COMPANY VTICMO12.6 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Male Required Intervention UNK.