BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 18665080 · Received February 7, 2024

    Report

    Report Number
    2023826-2024-00591
    Event Type
    Injury
    Date Received
    February 7, 2024
    Date of Event
    January 15, 2023
    Report Date
    February 3, 2024
    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

    ADDITIONAL DATA: H6- TYPE OF INVESTIGATION CODE: 3331- DEVICE HISTORY RECORD (DHR) REVIEW: BASED ON THE RESULTS OF THE INVESTIGATION, ALL RELEASED DEVICES FROM THE ASSOCIATED WORK ORDER(S), INCLUDING THE SUSPECTED DEVICE, HAVE BEEN MANUFACTURED WITHIN ESTABLISHED PROCESS PARAMETERS; AND THERE IS NO INDICATION THAT THE MANUFACTURING AND PROCESSING OF THE DEVICE CONTRIBUTED TO THE COMPLAINT ISSUE. CLAIM# (B)(4).

    Additional Manufacturer Narrative · 0

    H6 - TYPE OF INVESTIGATION: 4110 - LENS WORK ORDER SEARCH: NO SIMILAR COMPLAINT TYPE EVENTS REPORTED FOR UNITS WITHIN THE SAME LOT. CLAIM# (B)(4).

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: B5- THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM VTICMO 12.6 IMPLANTABLE COLLAMER LENS OF DIOPTER -10.0/+0.5/101 (SPHERE/CYLINDER/AXIS) INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. THE PATIENT EXPERIENCED A REFRACTIVE SURPRISE AND BLURRED VISION. ON (B)(6) 2023 THE LENS WAS EXCHANGED WITH A STRONGER POWER; SAME MODEL AND LENGTH AND THE PROBLEM WAS RESOLVED. THE REPORTER INDICATED EHE CAUSE OF THE EVENT IS UNKNOWN. CLAIM# (B)(4).

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: TYPE OF INVESTIGATION CODE: 10- DEVICE EVALUATION: THE LENS WAS RETURNED IN A MICROCENTRIFUGE VIAL WITH MOISTURE. VISUAL INSPECTION FOUND HAPTIC BENT. DIMENSIONAL INSPECTION FOUND THE LENS TO BE WITHIN SPECIFICATIONS. FUNCTIONAL INSPECTION FOUND THE RETURNED LENS DID NOT MEET ORIGINAL VALUES MEASURED AT THE TIME OF MANUFACTURING. CLAIM# (B)(4).

    Description of Event or Problem · 0

    THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VTICMO12.6; -10.0/0.5/101 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6)2023. THE PATIENT EXPERIENCED REFRACTIVE SURPRISE. ON (B)(6) 2023 THE LENS WAS EXCHANGED WITH A SAME LENGTH BUT DIFFERENT POWER LENS AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765341 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC TORIC INTRAOCULAR LENS QCB STAAR SURGICAL COMPANY VTICMO12.6 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Male Required Intervention CARTRIDGE MODEL-SFC-45, LOT#-UNK| FOAM TIP PLUNGER MODEL-FTP, LOT#-UNK| INJECTOR MODEL-MSI-PF, LOT#-UNK