BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN TICL IMPLANTABLE COLLAMER LENS)

    MDR report key: 4243426 · Received November 11, 2014

    Report

    Report Number
    2023826-2014-00874
    Event Type
    Injury
    Date Received
    November 11, 2014
    Date of Event
    September 23, 2014
    Report Date
    October 14, 2014
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS MANUFACTURED IN THE U.S. BUT NOT MARKETED IN THE U.S. DOB: UNK. IMPLANT AND EXPLANT DATES: UNK. EVENT PROBLEM CODES: (NEW INCISION); SIZE INCORRECT FOR PATIENT; LENS, REPOSITIONING OF. 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). LENS REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    THE ICL WAS EXPLANTED. DATE OF SURGERY NOT AVAILABLE. (B)(4). METHOD: MEDICAL REVIEW. RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND SMALL PIECE OF HAPTIC TORN OFF AND MISSING. LENS WAS RETURNED IN LIQUID. THE LENS WAS REHYDRATED IN BSS FOR RE-MEASUREMENT. THE MEASURED VALUE AFTER RE-HYDRATION IS AT THE EXPECTED OVERALL LENGTH VALUE AFTER COMPLETE IN-SITU HYDRATION. THE LENS IS IN SPECIFICATIONS. MEDICAL REVIEW: REVIEW OF THIS FILE INDICATES THAT ROTATION OF THE IMPLANT WAS NOTICED IN THE POST-OPERATIVE PERIOD. ICL VAULTING WAS CONSIDERED TO BE NORMAL. THERE IS NOT ENOUGH CLINICAL DATA TO DETERMINE THE EXACT CAUSE OF THIS EVENT. 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, ETC.). CONCLUSIONS: BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH, MEDICAL REVIEW AND THE EVALUATION OF THE RETURNED PRODUCT, THIS EVENT WAS NOT LENS RELATED, BUT A SPECIFIC ROOT CAUSE OF LENS ROTATION COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM VTICMO12.6 IMPLANTABLE COLLAMER LENS IN THE PATIENT'S RIGHT EYE. LENS ROTATION NOT ASSOCIATED TO A LOW VAULT. THE LENS WAS REPOSITIONED ON (B)(6) 2014. THIS DID NOT RESOLVE THE PROBLEM. AFTER REPOSITIONING, THE LENS ROTATED AGAIN. LENS REMAINS IMPLANTED. PLANNING TO EXCHANGE FOR LONGER LENS. PATIENT'S LAST DOCTOR VISIT ON (B)(6) 2014, UCVA: 20/50. SEE MFR REPORT # 2023826-2014-00875 FOR LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725250 VISIAN TICL IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY VTICMO12.6 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention INJECTOR MODEL AND LOT NUMBER - UNK| FOAM TIP PLUNGER MODEL AND LOT NUMBER - UNK| CARTRIDGE MODEL AND LOT NUMBER - UNK