BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 4182810 · Received October 17, 2014

    Report

    Report Number
    2023826-2014-00812
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    August 28, 2014
    Report Date
    September 18, 2014
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS MANUFACTURED IN THE U.S. BUT NOT MARKETED IN THE U.S. (B)(4) - (ENLARGEMENT OF INCISION); PUPILLARY BLOCK; INTRAOCULAR PRESSURE RISE; (SUTURE). (B)(4) - SIZE INCORRECT FOR PATIENT; (VAULTING); (EXPLANTED). DEVICE EVALUATED BY MANUFACTURER? NO. LENS NOT RETURNED. EVALUATION METHOD: WORK ORDER SEARCH. RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE WORK ORDER. CONCLUSIONS - (NO CONCLUSION CAN BE DRAWN): BASED ON THE COMPLAINT HISTORY AND WORK ORDER SEARCH, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION METHOD: MEDICAL REVIEW, DEVICE HISTORY RECORD REVIEW. RESULTS: 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). 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 VISCOELASTIC), 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), MALPOSITIONED FOOTPLATES, ETC. SEVERAL CONDITIONS MAY ARISE FROM THIS EVENT (I.E. PUPILLARY BLOCK, MALIGNANT GLAUCOMA, INCREASED IOP ETC.). TO PREVENT ANY OF THESE COMPLICATIONS FROM OCCURRING, STAAR 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. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NOTHING WAS FOUND IN THE MANUFACTURING PROCESS OF THIS LENS THAT WAS THE ROOT CAUSE OF THE COMPLAINT. CONCLUSIONS: BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH, DEVICE HISTORY RECORD REVIEW AND THE MEDICAL REVIEW, A PROBABLE 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).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED - THE REPORTER INDICATED THE PATIENT EXPERIENCED IRIS PROLAPSE (IT IS UNKNOWN IF THIS OCCURRED DURING THE FIRST INTERVENTION OR DURING REMOVAL OF THE ICL). THE IRIS WAS REPOSITIONED AND THE PATIENT EXPERIENCED MILD TEMPORAL IRIS ATROPHY AND ENLARGED PUPIL.

    Description of Event or Problem · 1

    THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM VICMO13.2 IMPLANTABLE COLLAMER LENS IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2014. THE LENS WAS EXPLANTED ON (B)(6) 2014 DUE TO EXCESSIVE VAULTING, PUPIL BLOCK AND ELEVATED INTRAOCULAR PRESSURE. THE INCISION WAS ENLARGED TO REMOVE THE LENS AND A SUTURE WAS REQUIRED. THE PATIENT'S POST-OP BEST-CORRECTED VISUAL ACUITY WAS 20/20.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661604 ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY VICMO13.2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention