BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 1002514 · Received February 26, 2008

    Report

    Report Number
    2023826-2008-00263
    Event Type
    Injury
    Date Received
    February 26, 2008
    Date of Event
    October 22, 2007
    Report Date
    February 7, 2008
    Manufacturer
    STAAR SURGICAL
    Product Code
    HQL
    PMA / PMN Number
    P030016
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 SULEUS, TO WHICH THE ICL SHOULD BE SIZED. THE CURRENT PRACTICE IN SELECTING AN APPROPRIATE ICL FOR A PATIENT IS TO MEASURE WHITE-TO-WHITE AND ANTERIOR CHAMBER DEPTH AND THROUGH CORRELATIVE ALGORITHM PREDICT THE LENGTH OF THE ICL THAT WILL BRIDGE THE SULEUS. THIS METHOD OF SIZING BASED UPON WHITE-TO-WHITE AND ANTERIOR CHAMBER DEPTH MEASUREMENTS WAS USED IN THE FDA CLINICAL TRIAL 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 A ICL IMPLANTABLE COLLAMER LENS MODEL ICM 115V4 IN 2007 AND EXPLANTED THE LENS ON NINE MONTHS LATER, DUE TO A LOW VAULT OF THE LENS. THE LENS WAS REPLACED WITH A LONGER LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS HQL STAAR SURGICAL ICM 115V4 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention FOAM TIP PLUNGER: UNK LOT NUMBER: UNK| INJECTOR MODEL: UNK LOT NUMBER: UNK| CARTRIDGE MODEL: UNK LOT NUMBER: UNK