BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2024281 · Received March 18, 2011

    Report

    Report Number
    2023826-2011-00228
    Event Type
    Injury
    Date Received
    March 18, 2011
    Date of Event
    March 22, 2010
    Report Date
    February 23, 2011
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: METHOD: LENS WORK ORDER SEARCH, MEDICAL REVIEW. RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND ONE SIMILAR COMPLAINT WAS FOUND WITHIN THE WORK ORDER. VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND ONE HAPTIC BROKEN. THE LENS WAS RETURNED DRY. THE LENS WAS REHYDRATED IN BSS FOR RE-MEASUREMENT. THE LENS LENGTH WAS MEASURED AND THE RESULT OF THE MEASUREMENT WAS COMPARED AGAINST THE ORIGINAL VALUE AND THE LENS WAS FOUND TO BE IN SPECIFICATION. MEDICAL REVIEW - ACCORDING TO USE FMEA (FAILURE MODES AND EFFECT ANALYSIS) IT HAS BEEN DETERMINED THAT EXCESSIVE VAULTING IS A CONSEQUENCE OF A WRONG LENS USE FAILURE MODE (I.E. IMPROPER WHITE TO WHITE MEASUREMENT, VARIABILITY OF THE WHITE TO WHITE MEASUREMENTS BASED UPON DIFFERENT TECHNIQUES UTILIZED, IMPROPER SULCUS TO SULCUS MEASUREMENT (IF UBM USED), AND PATIENT CONDITION; POOR CORRELATION OF WHITE TO WHITE MEASUREMENT AND LENGTH OF CILIARY SULCUS IN AN INDIVIDUAL CASE; IRREGULAR CILIARY SULCUS OR CILIARY SULCUS CYST). A HIGHER THAN IDEAL VAULTING IN THE ABSENCE OF SIGN AND/OR SYMPTOMS DOES NOT NEED AN EXCHANGE. HOWEVER, THE SURGEON MAY DECIDE TO EXCHANGE IF HE DETERMINES THAT THIS CONDITION MAY AFFECT THE OUTCOME OF THE PATIENT'S VISION. CONCLUSIONS: BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH, MEDICAL REVIEW AND THE EVALUATION OF THE RETURNED PRODUCT, THE ROOT CAUSE OF EXCESSIVE VAULTING HAS BEEN DETERMINED TO BE RELATED TO THE INACCURACY OF THE WHITE TO WHITE MEASUREMENT OR A MISMATCH BETWEEN WHITE TO WHITE AND THE SULCUS TO SULCUS DIAMETER. (B)(4).

    Additional Manufacturer Narrative · 1

    EVENT PROBLEM: (B)(4) - SURGICAL PROCEDURE, SECONDARY SURGERY. (B)(4) - EXPLANTED, UNLABELED; LENS, VAULTING, EXCESSIVE. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.5MM ICM125V4 IMPLANTABLE COLLAMER LENS IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2010. THE LENS WAS EXPLANTED ON (B)(6) 2010 DUE TO EXCESSIVE VAULTING. THE ICL WAS EXCHANGED FOR A SHORTER LENS WHICH RESOLVED THE PROBLEM. AT THE LAST POST-OP VISIT THE PATIENT'S BCVA WAS 20/20.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY ICM125V4

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention FOAM TIP PLUNGER: MODEL AND LOT NUMBER UNKNOWN| INJECTOR: MODEL AND LOT NUMBER UNKNOWN| CARTRIDGE: MODEL AND LOT NUMBER UNKNOWN