BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2200428 · Received August 11, 2011

    Report

    Report Number
    2023826-2011-00709
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    June 24, 2011
    Report Date
    July 13, 2011
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) SURGICAL PROCEDURE, PERIPHERAL IRIDOTOMY. (B)(4) VAULTING, EXCESSIVE. LENS WORK ORDER SEARCH, MEDICAL REVIEW. THE ICL WAS RETURNED FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND ONE HAPTIC TORN. THE LENS WAS RETURNED DRY. THERE WAS EVIDENCE OF CLEAR SURGICAL RESIDUE. 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 NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE WORK ORDER. PER MEDICAL REVIEW - EARLY PUPIL BLOCK/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), MALPOSITIONED 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 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). 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 PATIENTS VISION. 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

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED - THE ICL WAS EXPLANTED DUE TO EXCESSIVE VAULTING. THE SURGEON PERFORMED AN ADDITIONAL PERIPHERAL IRIDOTOMY.

    Description of Event or Problem · 1

    THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.5MM ICM125V4 IMPLANTABLE COLLAMER LENS IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2011. THE LENS WAS EXPLANTED ON (B)(6) 2011 DUE TO PUPIL BLOCK WITH ELEVATED IOP. THE ICL WAS EXCHANGED FOR A SHORTER LENS. THE PATIENT HAS BEEN EXPERIENCING NAUSEA.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention INJECTOR MODEL AND LOT NUMBER UNKNOWN| CARTRIDGE MODEL AND LOT NUMBER UNKNOWN| FOAM TIP PLUNGER MODEL AND LOT NUMBER UNKNOWN