BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICM (IMPLANTABLE COLLAMER LENS)

    MDR report key: 1040287 · Received May 8, 2008

    Report

    Report Number
    2023826-2008-00644
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    February 22, 2008
    Report Date
    April 14, 2008
    Manufacturer
    STAAR SURGICAL
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: CONCLUSIONS: AT THE CONCLUSION OF THE ORIGINAL INVESTIGATION OPENED FOR THE ISSUE OF ICL VAULTING (BOTH INADEQUATE AND EXCESSIVE), IT WAS DETERMINED THAT THE MOST LIKELY ROOT CAUSE FOR BOTH INADEQUATE AND EXCESSIVE VAULT IS DIFFICULTY IN CLINICAL SIZING. IN NO CASE HAS A RETURNED LENS EXHIBITED A LENGTH MEASUREMENT OUTSIDE THE EXPECTED RANGE ACCORDING TO THE LABELED LENGTH. PRE-OPERATIVE MEASUREMENT TECHNOLOGY AVAILABLE TO CLINICIANS IN THE PAST DID NOT PROVIDE A DIRECT MEASUREMENT OF THE SULCUS, TO WHICH THE ICL SHOULD BE SIZED. THE CURRENT PRACTICE IN SELECTING AN APPROPRIATE ICL FOR A PT IS TO MEASURE WHITE-TO-WHITE AND ANTERIOR CHAMBER DEPTH AND, THROUGH CORRELATIVE ALGORITHM PREDICT THE LENGTH OF THE ICL THAT WILL BRIDGE THE SULCUS. THIS METHOD OF SIZING BASED UPON WHITE-TO-WHITE AND ANTERIOR CHAMBER DEPTH MEASUREMENTS WAS USED IN THE FDA CLINICAL TRAIL AND IS RECOMMENDED IN THE CURRENT LABELING OF THE ICL. IF THE PREDICTED LENGTH IS TOO SHORT, THE RESULT MAY BE AN INADEQUATE VAULT. IF PREDICTED LENGTH IS TOO LONG, THE RESULT MAY BE AN EXCESSIVE VAULT.

    Description of Event or Problem · 1

    THE REPORTER STATED, THAT THE SURGEON INSERTED AN (IMPLANTABLE COLLAMER LENS) MODEL ICM 125V4 IN 2008 AND DUE TO AN EXCESSIVE VAULT OF THE LENS CAUSING A NARROWING OF THE ANGLE AND SHALLOWING OF THE ANTERIOR CHAMBER DEPTH, THE SURGEON EXPLANTED THE LENS ONE MONTHS LATER, AND EXCHANGED IT FOR A SHORTER LENGTH LENS. TWO IRIDOTOMIES WERE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICM (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL ICM125V4 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention FOAM TIP PLUNGER: FTP| INJECTOR MODEL: MSI-PF| CARTRIDGE MODEL: SFC-45FP