BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 17814792 · Received September 25, 2023

    Report

    Report Number
    2023826-2023-04276
    Event Type
    Injury
    Date Received
    September 25, 2023
    Date of Event
    July 31, 2023
    Report Date
    August 31, 2023
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    QCB
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITONAL DATA: B5- THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM VTICMO_12.6 IMPLANTABLE COLLAMER LENS OF DIOPTER -12.5/+2.0/85 (SPHERE/CYLINDER/AXIS) INTO THE RIGHT EYE (OD) (B)(6)2023. THE PATIENT EXPERIENCED AN EXCESSIVE VAULT AND REFRACTIVE SURPRISE. ON (B)(6) 2023 THE LENS WAS EXCHANGED WITH A DIFFERENT MODEL, SHORTER LENGTH LENS AND THE PROBLEM WAS RESOLVED. ADDITIONAL INFORMATION PROVIDED: "ALL WELL AFTER EXCHANGE". THE REPORTER INDICATED THE CAUSE OF THE EVENT IS UNKNOWN. H6- HEALTH EFFECT- IMPACT CODE: "2199" SHOULD BE REMOVED AND "4629" SHOULD BE ADDED. H6- MEDICAL DEVICE CODE: "2993" SHOULD BE ADDED. 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 -12.5/+2.0/85 (SPHERE/CYLINDER/AXIS) INTO THE RIGHT EYE (OD) (B)(6) 2023. THE PATIENT EXPERIENCED AN EXCESSIVE VAULT AND REFRACTIVE SURPRISE. THE LENS REMAINS IMPLANTED CLAIM# (B)(4).

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: H3 TYPE OF INVESTIGATION CODE: 10 DEVICE EVALUATION: THE LENS WAS RETURNED DRY IN A VIAL WITH RESIDUE/DEBRIS ON PRODUCT. VISUAL INSPECTION FOUND HAPTIC BROKEN. 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. (B)(4).

    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 - LENS WORK ORDER SEARCH: NO SIMILAR COMPLAINT TYPE EVENTS REPORTED FOR UNITS WITHIN THE SAME LOT. (B)(4).

    Description of Event or Problem · 0

    THE REPORTER INDICATED THAT A 12.6MM VTICMO12.6 IMPLANTABLE COLLAMER LENS OF -12.5/2.0/085 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON 31-JUL-2023. THE REPORTER REPORTS EXCESSIVE VAULT AND STATES THAT THERE IS STILL RESIDUAL ASTIGMATISM, LENS REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1097252 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC TORIC INTRAOCULAR LENS QCB STAAR SURGICAL COMPANY VTICMO12.6 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female Required Intervention