BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2932462 · Received January 24, 2013

    Report

    Report Number
    2023826-2013-00094
    Event Type
    Injury
    Date Received
    January 24, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 9, 2013
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: MEDICAL REVIEW. RESULTS: MEDICAL REVIEW - REVIEW OF THIS FILE INDICATES THAT THE PATIENT HAD A REFRACTIVE SURPRISE AFTER IMPLANTATION OF THE ICL. THE ICL WAS EXCHANGED WITH A DIFFERENT POWER WHICH RESOLVED THE PROBLEM. IT IS HIGHLY UNLIKELY THAT THE POWER OF THE ICL IS INCORRECT OR LABELED INCORRECTLY SINCE THE PROBLEM WAS RESOLVED AFTER EXCHANGE WITH A DIFFERENT POWER. THIS EVENT IS MOST LIKELY CAUSED BY INACCURATE REFRACTIONS PRIOR TO CALCULATION OF THE LENS POWER TO BE IMPLANTED. CONCLUSIONS: BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH, MEDICAL REVIEW AND THE EVALUATION OF THE RETURNED PRODUCT, THE MOST LIKELY CAUSE OF THE EVENT IS INACCURATE REFRACTIONS PRIOR TO CALCULATION OF THE LENS POWER TO BE IMPLANTED. (B)(4).

    Additional Manufacturer Narrative · 1

    METHOD: LENS WORK ORDER SEARCH. RESULTS: A VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND A PIECE OF PLATE HAPTIC IS TORN OFF AND MISSING. LENS WAS RETURNED DRY. THERE WAS EVIDENCE OF CLEAR SURGICAL RESIDUE. A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE SAME WORK ORDER. CONCLUSION: (NO CONCLUSION CAN BE DRAWN): BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).

    Additional Manufacturer Narrative · 1

    RESULTS: THE LENS WAS REHYDRATED IN BSS FOR RE-MEASUREMENT. THE LENS LENGTH, WIDTH AND DIOPTER POWER WERE MEASURED AND THE RESULTS OF THE MEASUREMENTS WERE COMPARED AGAINST THE ORIGINAL VALUES AND THE LENS WAS FOUND TO BE IN SPECIFICATION. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON IMPLANTED A MICL 12.6MM IMPLANTABLE COLLAMER LENS IN THE PATIENT'S RIGHT EYE ON (B)(6) 2012. STATED THERE WAS OVERVAULT. THE DOCTOR SAW THE PATIENT ON (B)(6) 2013, THE VAULT WAS FINE BUT STILL AT +1. OVERCORRECTED AND PATIENT'S VISION HAD IMPAIRED. SURGERY FOR REMOVAL OF IMPLANTED LENS AND EXCHANGED FOR A SAME SIZE, DIFFERENT DIOPTER. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN FURTHER INFORMATION IS AVAILABLE. SEE MFR#2023826-2013-00093 FOR RIGHT EYE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED - THE FACILITY REPORTED THE PATIENT IS DOING WELL AND THE VISION IS 20/20 DISTANCE, J1 UPCLOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34568 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL CO. MICL12.6 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention FOAM TIP PLUNGER: MODEL- LOT NUMBER- UNK| CARTRIDGE: MODEL AND LOT NUMBER- UNK| INJECTOR: MODEL AND LOT NUMBER- UNK