BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 4111400 · Received September 23, 2014

    Report

    Report Number
    2023826-2014-00726
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    May 20, 2014
    Report Date
    August 26, 2014
    Manufacturer
    STAAR SURGICAL COMPANY
    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

    METHOD: MEDICAL REVIEW. RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWED NO VISIBLE DAMGE TO THE LENS. THE LENS WAS REHYDRATED AND BOTH THE LENGTH AND WIDTH WERE REMEASURED AND FOUND TO BE WITHIN ORIGINAL DESIGN SPECIFICATIONS. MEDICAL REVIEW - THERE IS NOT ENOUGH INFORMATION TO DETERMINE A SPECIFIC ROOT CAUSE OF THE EVENT, HOWEVER, IT SEEMS THAT THE FIRST LENS BEHAVED AS BEING SHORT, AND DURING IMPLANTATION OF THE LONGER LENS, AQUEOUS PASSAGE WAS BLOCKED. THIS MAY BE DUE TO VISCOELASTIC RETENTION WITH FURTHER MOVEMENT OF THE ICL FORWARD CLOSING ANGLES. CLINICAL STUDIES HAVE SHOWN THAT TORIC ICL ROTATION OCCURS IN 0.5% OF PATIENTS WHERE A TICL HAS BEEN IMPLANTED. SEVERAL FACTORS MAY CONTRIBUTE TO THIS PHENOMENON (I.E. PATIENT'S ANATOMICAL STRUCTURE, A SHORT LENS, HAPTIC POSITION, ECT.). ACUTE ELEVATED IOP IN THE PRESENCE OF HIGH VAULT EARLY ICL IMPLANTATION MAY OCCUR DUE TO: 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 CYST), MAL-POSITIONED FOOTPLATES, UPSIDE DOWN LENS, ECT. CONCLUSIONS: BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH, MEDICAL REVIEW AND THE EVALUATION OF THE RETURNED PRODUCT, WE WERE UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE OF THE EVENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SURGEON IMPLANTED AN 13.2MM VTICMO13.2 IMPLANTABLE COLLAMER LENS ON (B)(6) 2014 IN PATIENT'S LEFT EYE AND THE LENS WAS REMOVED DUE TO PUPIL BLOCK WITH ELEVATED IOP, ASSOCIATED WITH EXCESSIVE VAULT. THE LAST UCVA WAS 20/30. THE LENS WAS NOT REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589934 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY VTICMO13.2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR