BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 1962848 · Received January 12, 2011

    Report

    Report Number
    2023826-2011-00042
    Event Type
    Injury
    Date Received
    January 12, 2011
    Date of Event
    November 29, 2010
    Report Date
    December 21, 2010
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) SECONDARY SURGERY. (B)(4) EXCESSIVE. (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION: METHOD - LENS WORK ORDER SEARCH, MEDICAL REVIEW. RESULTS - VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND NO VISIBLE DAMAGE TO THE LENS. 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. A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE WORK ORDER. PER 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 - (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 REPORTED STATED THE SURGEON IMPLANTED A 12.5MM ICM125V4 IMPLANTABLE COLLAMER LENS IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2010. THE LENS WAS EXPLANTED ON (B)(6) 2010 DUE TO EXCESSIVE VAULTING. THE ICL WAS EXCHANGED FOR A SHORTER LENS.

    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 26 YR Required Intervention INJECTOR: MODEL AND LOT NUMBER UNKNOWN| FOAM TIP PLUNGER: MODEL AND LOT NUMBER UNKNOWN| CARTRIDGE: MODEL AND LOT NUMBER UNKNOWN