BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 22890242 · Received August 25, 2025

    Report

    Report Number
    2023826-2025-01239
    Event Type
    Injury
    Date Received
    August 25, 2025
    Date of Event
    May 17, 2025
    Report Date
    August 25, 2025
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    QCB
    UDI-DI
    00840311312054
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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. H6 - HEALTH EFFECT CLINICAL CODE: 4581 - PIGMENT DISPERSION. H11: MANUFACTURE NARRATIVE: IRIS PIGMENT DISPERSION IS IDENTIFIED IN THE LABELING AS A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING ICL IMPLANTATION. H11: MANUFACTURE NARRATIVE: INFLAMMATION IS IDENTIFIED IN THE LABELING AS A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING ICL IMPLANTATION. THE DFU PROVIDES THE SURGEON INSTRUCTION FOR COMPLETE OVD REMOVAL. PRECAUTION: (6) AFTER INSERTING THIS PRODUCT, ASPIRATE THE VISCOELASTIC SUBSTANCE COMPLETELY FROM INSIDE THE EYE. DO NOT USE HIGHLY VISCOUS VISCOELASTIC SUBSTANCES THAT ARE DIFFICULT TO ASPIRATE COMPLETELY. CLAIM #: (B)(4).

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE THE PATIENT EXPERIENCED ENDOPHTHALMITIS, "ASEPTIC INFLAMMATION WITH PIGMENT CELL DEPOSITION," DIAGNOSTIC CULTURES AND TREATMENT WERE PERFORMED, PUPIL IMPAIRMENT. THE LENS REMAINS IMPLANTED, AND MEDICATION TREATMENT WAS ADMINISTERED. THE CAUSE OF THE EVENT WAS REPORTED UNKNOWN. THIS REPORT IS PART OF A BOLUS SUBMISSION OF INDIVIDUALLY REPORTED EVENTS IDENTIFIED DURING A RETROSPECTIVE REVIEW BY THE CUSTOMER COVERING A SIX-MONTH PERIOD. EACH CASE IS SUBMITTED SEPARATELY AND DOES NOT INDICATE A TEMPORAL CLUSTER. THIS TIMELINE ALSO HIGHLIGHTS A DELAYED ONSET OF THE BOLUS REPORTED EVENTS RELATIVE TO THE PROCEDURE DATE (AVERAGE: 26 DAYS, RANGE:17-35 DAYS, AS WELL AS A DELAY IN REPORTING DUE TO RETROSPECTIVE CASE IDENTIFICATION. THIS REPORT IS 1 OF 2 TOTAL REPORTS. BASED ON THE INFORMATION PROVIDED, THE RISK ASSESSMENT FOR OUR PRODUCT, AND OUR EXPERIENCE, WE HAVE DETERMINED THE CAUSE OR CONTRIBUTION TO THE REPORTED ISSUE IS NOT INDICATIVE OF A MANUFACTURING RELATED ISSUE OR PRODUCT DEFICIENCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1601490 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC TORIC INTRAOCULAR LENS QCB STAAR SURGICAL COMPANY VTICM5_13.2 (- 11.50/2.5) N/A 00840311312054

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female Required Intervention