BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 19951407 · Received August 9, 2024

    Report

    Report Number
    2023826-2024-03614
    Event Type
    Injury
    Date Received
    August 9, 2024
    Report Date
    August 7, 2024
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    QCB
    UDI-DI
    00840311307807
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6- INVESTIGATION TYPE CODE: 4110- LENS WORK ORDER SEARCH-NO SIMILAR COMPLAINT EVENT(S) WITHIN ASSOCIATED LOTS WERE FOUND. H11- MANUFACTURER NARRATIVE: SECONDARY SURGICAL INTERVENTION TO REMOVE/REPLACE/REPOSITION THE LENS IS IDENTIFIED IN THE LABELING AS A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING ICL IMPLANTATION. EACH LENS IS SUBJECTED TO A 100% ASSESSMENT OF THE POWER (SPHERICAL AND CYLINDER) AND OPTICAL RESOLUTION DURING THE MANUFACTURING PROCESS IN ORDER TO DETERMINE ACCEPTABILITY PER THE LENS MODEL AND DIOPTER. CLAIM# (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: A2."01-JAN-1975" SHOULD BE REMOVED AND "28-JUN-1992" SHOULD BE ADDED. (B)(4).

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: H3: TYPE OF INVESTIGATION CODE: 10- DEVICE EVALUATION: THE LENS WAS RETURNED IN A VIAL WITH LIQUID. VISUAL INSPECTION FOUND NO VISIBLE DAMAGE. DIMENSIONAL AND FUNCTIONAL INSPECTION FOUND THE LENS TO BE WITHIN SPECIFICATIONS. CORRECTION: B5: A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED REFRACTIVE SURPRISE AND BLURRED VISION. IN A SEPARATE VISIT THE LENS WAS EXCHANGED WITH THE SAME MODEL/ LENGTH, DIFFERENT POWER LENS AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS A PATIENT RELATED FACTOR AND THE DEVICE FAILED TO PERFORM AS INTENDED. CAUSE DETAILS PROVIDED: "THE EXPECTED SEQ FROM OCOS LENS CALCULATION WAS -00.01 WITH EXPECTED ASTIGMATISM OF +00.10. HOWEVER, PATIENTS POST-OP REFRACTION WAS PLANO -1.25X10. HENCE, PATIENT REPORTED BLUR DISTANCE VISION" 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 REFRACTIVE SURPRISE. IN A SEPARATE VISIT THE LENS WAS EXCHANGED WITH THE SAME MODEL/ LENGTH, DIFFERENT POWER LENS AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS A PATIENT RELATED FACTOR AND THE DEVICE FAILED TO PERFORM AS INTENDED. CAUSE DETAILS PROVIDED: "THE EXPECTED SEQ FROM OCOS LENS CALCULATION WAS -00.01 WITH EXPECTED ASTIGMATISM OF +00.10. HOWEVER, PATIENTS POST-OP REFRACTION WAS PLANO -1.25X10. HENCE, PATIENT REPORTED BLUR DISTANCE VISION".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2493334 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC TORIC INTRAOCULAR LENS QCB STAAR SURGICAL COMPANY VTICM5_12.6 NA 00840311307807

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention CARTRIDGE MODEL: SFC-45: LOT# UNK| FOAM TIP PLUNGER (FTP), LOT# UNK| MSI-PF, LOT# UNK