BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 1000482 · Received February 21, 2008

    Report

    Report Number
    2023826-2008-00215
    Event Type
    Injury
    Date Received
    February 21, 2008
    Date of Event
    December 20, 2007
    Report Date
    January 28, 2008
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P030016
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    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 SULCUS, 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 ALGORITHMS, 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 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 THE PREDICTED LENGTH IS TOO LONG, THE RESULT MAY BE AN EXCESSIVE VAULT. EVALUATION OF NEWLY AVAILABLE, ALTERNATE MEASURING DEVICES IS ONGOING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON INSERTED AN ICM 120V4 12.0MM IMPLANTABLE COLLAMER LENS IN 2007. DURING THE PT'S LAST VISIT, THE SURGEON DISCOVERED INADEQUATE VAULTING OF THE LENS AND THE PT WAS EXPERIENCING INTENSE PHOTOPHOBIA. THE LENS REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS HQL STAAR SURGICAL CO. ICM120V4 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR FOAM TIP PLUNGER: MODEL, LOT NUMBER UNK| CARTRIDGE: MODEL UNK, LOT NUMBER UNK| INJECTOR: MODEL UNK, LOT NUMBER UNK