BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 16065468 · Received December 28, 2022

    Report

    Report Number
    2023826-2022-04742
    Event Type
    Injury
    Date Received
    December 28, 2022
    Date of Event
    January 15, 2022
    Report Date
    November 29, 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

    D4 - UNIQUE IDENTIFER (UDI)# (B)(4). SHOULD BE ADDED TO THE INITAL MDR. CLAIM # (B)(4).

    Additional Manufacturer Narrative · 0

    D4: CORRECTED TO: SERIAL#: (B)(6) IN THE INITIAL MDR. D4: CORRECTED TO: UNIQUE IDENTIFIER (UDI)#: N/A. CLAIM#: (B)(4).

    Additional Manufacturer Narrative · 0

    H3 - DEVICE EVALUATION: THE LENS WAS RETURNED DRY WITH RESIDUE IN A MICROCENTRIFUGE VIAL. VISUAL INSPECTION FOUND OPTIC DEFORMED AND HAPTIC BENT/DEFORMED TO THE LENS. DIMENSIONAL INSPECTION FOUND THE LENS TO BE WITHIN SPECIFICATIONS. CLAIM# (B)(4).

    Additional Manufacturer Narrative · 0

    WORK ORDER SEARCH: NO SIMILAR COMPLAINTS WITHIN ASSOCIATED LOTS WERE FOUND. CLAIM# (B)(4).

    Description of Event or Problem · 0

    THE REPORTER INDICATED THAT A 13.2MM VTICMO13.2 IMPLANTABLE COLLAMER LENS OF -11.5/1.5/092 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2021. ON (B)(6) 2022, THE LENS WAS EXCHANGED FOR A SAME MODEL, SAME SIZE LENS DUE TO LENS ROTATION NOT ASSOCIATED WITH LOW VAULT. REPORTEDLY, "THE FIRST LENS WAS IMPLANTED AT CCQ 23." THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1923677 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC TORIC INTRAOCULAR LENS QCB STAAR SURGICAL COMPANY VTICMO13.2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Male Required Intervention UNK.