BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 21293025 · Received February 3, 2025

    Report

    Report Number
    2023826-2025-00137
    Event Type
    Injury
    Date Received
    February 3, 2025
    Date of Event
    January 11, 2025
    Report Date
    January 13, 2025
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    QCB
    UDI-DI
    07640145869822
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION; B5 - REPORTED AS; A HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED UVEITIS (UGH) AND PIGMENT DISPERSION. MEDICATION WAS PRESCRIBED. LENS REMAINS IMPLANTED. DIAGNOSTIC CULTURES HAVE NOT BEEN REPORTED. ADDITIONAL INFORMATION WAS REQUESTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS FILE WILL BE RE-OPENED IF ADDITIONAL INFORMATION IS PROVIDED. THERE ARE MULTIPLE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS 1 OF 2 TOTAL REPORTS. - CORRECT TO: A HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED UVEITIS (UGH) AND PIGMENT DISPERSION. MEDICATION WAS PRESCRIBED. IN A SEPARATE VISIT THE LENS WAS EXPLANTED AND PROBLEM RESOLVED. DIAGNOSTIC CULTURES HAVE NOT BEEN REPORTED. THERE ARE MULTIPLE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS 1 OF 2 TOTAL REPORTS. H6 - IMPACT CODE(F) - ALSO REPORT; 4627. CORRECT DATA: B2 - REPORTED AS; OTHER SERIOUS OR IMPORTANT MEDICAL EVENTS - CORRECT TO; REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE. CLAIM# (B)(4).

    Additional Manufacturer Narrative · 0

    A4 - UNK. A5 - UNK. A6 - UNK. H6 - IMPACT CODE: 4644 - MAXIDEX (QID), NEVANAC (TDS). H6 - WORK ORDER SEARCH: NO SIMILAR COMPLAINT TYPE EVENTS WERE REPORTED FOR UNITS WITHIN THE SAME LOT. CLAIM# (B)(4). MANUFACTURER NARRAVTIVE: IRITIS IS AN INFLAMMATORY CONDITION WHICH IS COMMON AFTER INTRA-OCULAR SURGERY, HOWEVER THIS IS USUALLY MILD AND DOES NOT REQUIRE ANY ADDITIONAL INTERVENTIONS BEYOND THE STANDARD POST-OP REGIMEN. IN SOME CASES, THE DEGREE OF INFLAMMATION MAY BE MORE SEVERE AND REQUIRE EXTENDED STEROID TREATMENT. PROCEDURAL FACTORS INCLUDING EXCESSIVE SURGICAL MANIPULATION AND THE USE OF PRO-INFLAMMATORY SUBSTANCES IN THE EYE MAY HAVE CONTRIBUTED TO THE EVENT. MECHANICAL INSULT TO THE IRIS CAN RESULT IN A PROLONGED OR STRONGER INFLAMMATORY RESPONSE. AN EXACT CAUSE COULD NOT BE DETERMINED AS THE EVENT COULD BE MULTIFACTORIAL IN NATURE INCLUDING PATIENT AND/OR PROCEDURE RELATED FACTORS.

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED UVEITIS (UGH) AND PIGMENT DISPERSION. MEDICATION WAS PRESCRIBED. LENS REMAINS IMPLANTED. DIAGNOSTIC CULTURES HAVE NOT BEEN REPORTED. ADDITIONAL INFORMATION WAS REQUESTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS FILE WILL BE RE-OPENED IF ADDITIONAL INFORMATION IS PROVIDED. THERE ARE MULTIPLE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS 1 OF 2 TOTAL REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1388177 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC TORIC INTRAOCULAR LENS QCB STAAR SURGICAL COMPANY VTICM5_12.1 N/A 07640145869822

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Female Other CARTRIDGE MODEL#SFC-45,LOT#UNK| FOAMTIPPLUNGER MODEL#FTP,LOT#UNK| INJECTOR MODEL#MSI-PF,LOT#UNK