BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 4251211 · Received November 14, 2014

    Report

    Report Number
    2023826-2014-00861
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    June 11, 2014
    Report Date
    October 20, 2014
    Manufacturer
    STAAR SURGICAL COMPANY AG
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PT WEIGHT: UNK. (B)(4). CONCLUSIONS: (NO CONCLUSION CAN BE DRAWN): BASED ON THE COMPLAINT HISTORY, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4). LENS NOT RETURNED.

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWED THE LENS WAS RETURNED DRY WITH NO VISIBLE DAMAGE. THE LENS WAS RE-HYDRATED AND BOTH THE LENGTH AND WIDTH WERE RE-MEASURED AND FOUND TO BE WITHIN ORIGINAL DESIGN SPECIFICATIONS. A LENS WORK ORDER SEARCH REVEALED THERE WERE ONE SIMILAR COMPLAINT WITHIN THE WORK ORDER. 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. STAAR RECOMMENDS THE ICL TO BE LEFT IMPLANTED IF NO CATARACTS ARE NOTED OR IN CASES WHERE THERE IS A TRACE ANTERIOR SUB-CAPSULAR CATARACT WITH NO PROGRESSION. STAAR BELIEVES THAT THE ACTION TO REMOVE AND/OR REPLACE THE ICL INCREASE THE RISK FOR ANTERIOR SUB-CAPSULAR CATARACT. BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH, MEDICAL REVIEW AND THE EVALUATION OF THE RETURNED PRODUCT, A PROBABLE ROOT CAUSE OF LOW 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

    THE REPORTER INDICATED THE SURGEON IMPLANTED AN 11.5MM ICM115V4 IMPLANTABLE COLLAMER LENS IN PATIENT'S RIGHT EYE ON (B)(6) 2012. A ANTERIOR SUBCAPSULAR CATARACT WAS OBSERVED ON (B)(6) 2014. THE LENS WAS EXPLANTED ON (B)(6) 2014 DUE TO LOW VAULT. THE LENS WAS EXCHANGED FOR A LONGER LENGTH LENS. PATIENT'S LAST DOCTOR VISIT ON (B)(6) 2014, UCVA: 20/20.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736168 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY AG ICM115V4 NA

    Patients

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