BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 1961390 · Received January 7, 2011

    Report

    Report Number
    2023826-2011-00025
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    December 2, 2010
    Report Date
    December 15, 2010
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION: METHOD: LENS WORK ORDER SEARCH, MEDICAL REVIEW. RESULTS: THE ICL WAS RETURNED FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND NO VISIBLE DAMAGE TO THE LENS. THE LENS WAS RETURNED IN LIQUID. 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. A LENS WORK ORDER SEARCH WAS PERFORMED AND ONE SIMILAR COMPLAINT WAS FOUND WITHIN THE WORK ORDER. MEDICAL REVIEW - ACUTE ANGLE CLOSURE/PUPILLARY BLOCK WITH ELEVATED IOP IN THE PRESENCE OF HIGH VAULT EARLY AFTER ICL IMPLANTATION MAY OCCUR DUE TO: NON PATENT/FUNCTIONING IRIDECTOMIES (TOO SMALL, TOO PERIPHERAL AND/OR NOT FULLY PERMEABLE, BLOCKED BY VISCO), REMAINING VISCOELASTIC IN THE POSTERIOR CHAMBER, OVERSIZED ICL WITH ANGLE CLOSURE, TOO NARROW ANGLES/CROWDED AC DUE TO SMALL EYE ANATOMY PREOPERATIVELY, UNEXPECTED ABNORMAL ANATOMY OR TISSUE ABNORMALITIES (PRESENCE OF IRIS/CILIARY BODY CYSTS), MAL-POSITIONED FOOTPLATES, ETC. 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 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). SEVERAL CONDITIONS MAY ARISE FROM THIS EVENT (I.E. PUPILLARY BLOCK, MALIGNANT GLAUCOMA, INCREASED IOP ETC.). TO PREVENT ANY OF THESE COMPLICATIONS FROM OCCURRING, THE MANUFACTURER RECOMMENDS THAT THE LENS BE EXPLANTED AND/OR EXCHANGED WITH THE RIGHT SIZE ONCE THE SURGEON DETERMINES THAT THIS CONDITION MAY AFFECT THE OUTCOME OF THE PATIENT'S VISION. CONCLUSIONS - (NO CONCLUSION CAN BE DRAWN): BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH, MEDICAL REVIEW AND THE EVALUATION OF THE RETURNED PRODUCT, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.5MM (B)(4) IMPLANTABLE COLLAMER LENS IN THE PT'S RIGHT EYE (OD) ON (B)(6) 2010. THE LENS WAS EXPLANTED ON (B)(6) 2010 DUE TO EXCESSIVE VAULTING. SUBSEQUENTLY, THE PT EXPERIENCED PUPIL BLOCK WITH ELEVATED IOP AND ANGLE CLOSURE. THE ICL WAS EXCHANGED FOR A VICM 12.5 LENS, -8.5 DIOPTER, WHICH WAS IMPLANTED ON (B)(6) 2010. THE PT'S BCVA WAS 20/15 AND THE PT IS VERY HAPPY WITH THE IMPLANT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention FOAM TIP PLUNGER: MODEL AND LOT# UNK| CARTRIDGE: MODEL AND LOT# UNK| INJECTOR: MODEL AND LOT# UNK