BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 939544 · Received November 8, 2007

    Report

    Report Number
    2023826-2007-01894
    Event Type
    Injury
    Date Received
    November 8, 2007
    Report Date
    October 11, 2007
    Manufacturer
    STAAR SURGICAL
    Product Code
    HQL
    PMA / PMN Number
    P030016
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: A WORK ORDER SEARCH WAS PERFORMED FOR THE LENS SERIAL FOR SIMILAR COMPLAINTS WITHIN THE SEARCH AND THERE WERE NO SIMILAR COMPLAINTS. 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 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 IMPLANTED A VISIAN ICL (IMPLANTABLE COLLAMER LENS MODEL MICL 12.6 MM AND NOTICED AT PT'S 12 MONTH POST OP VISIT THAT THE PT HAD AN ANTERIOR SUBCAPSULAR CATARACT AND EXPLANTED THE MICL AND PERFORMED A CATARACT EXTRACTION AND PUT IN AN IOL. THIS WAS DUE TO AN INADEQUATE VAULTING OF THE MICL DUE TO MISMANAGEMENT OF THE PATIENTS' EYE AND TOO SMALL OF A LENS INSERTED. FURTHER INFO HAS BEEN REQUESTED BUT NONE FORTH COMING. IF MORE INFO IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT FORM WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS HQL STAAR SURGICAL MICL 12.6 NA

    Patients

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