BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 1760712 · Received July 13, 2010

    Report

    Report Number
    2023826-2010-00695
    Event Type
    Injury
    Date Received
    July 13, 2010
    Date of Event
    May 20, 2010
    Report Date
    June 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
    NOT APPLICABLE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4): EVALUATION RESULTS: A WORK ORDER SEARCH WAS PERFORMED AND THERE WERE NO SIMILAR COMPLAINTS FOUND. CONCLUSION: BASED ON THE COMPLAINT HISTORY AND WORK ORDER SEARCH, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B) (4).

    Additional Manufacturer Narrative · 1

    RESULTS: REVIEW OF THIS FILE INDICATES THAT PATIENT DEVELOPED ANTERIOR AND CORTICAL CATARACT BUT NOT CLINICALLY SIGNIFICANT TO REMOVE. ANTERIOR SUBCAPSULAR CATARACT IS A LABELED COMPLICATION IN THE IMPLANTATION OF AN ICL. THE POSSIBLE CAUSES OF THIS CONDITION IS DETERMINED TO BE SECONDARY TO ANTERIOR CAPSULAR TOUCH DURING THE SURGERY, ICL TOUCH FOLLOWING INADEQUATE VAULTING OR EXCESSIVE MANIPULATION DURING THE LEARNING CURVE. CATARACT EXTRACTION MAY BE NECESSARY IF VISION IS COMPROMISED, TO PRECLUDE INCREASE IN SEVERITY OF THE CONDITION. IF THE CONDITION IS NON-PROGRESSIVE, THE SURGEON MAY OPT TO LEAVE THE ICL, ESPECIALLY WHEN THERE IS NO DECREASE IN VISUAL ACUITY. (B)(4) WAS PERFORMED TO INVESTIGATE THE ROOT CAUSE OF INADEQUATE VAULTING. IT HAS BEEN DETERMINED THAT THIS COMPLICATION IS RELATED TO INACCURATE WHITE TO WHITE MEASUREMENT. THIS IS USUALLY SECONDARY TO A MISMATCH BETWEEN WHITE TO WHITE AND THE SULCUS DIAMETER. CONCLUSION: (NO DEVICE FAILURE), BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH AND MEDICAL REVIEW, THE MOST LIKELY ROOT CAUSE OF THE EVENT IS INACCURATE WHITE TO WHITE MEASUREMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD A MICL12.6 IMPLANTABLE COLLAMER LENS IMPLANTED IN LEFT EYE ON (B) (6)2008. AS PART OF THE MICL POSTMARKET STUDY, THE PT REPORTED A LOSS OF VISION DUE TO THE DEVELOPMENT OF A CATARACT. ADDITIONAL INFORMATION WAS REQUESTED FROM THE SURGEON BUT NOT YET RECEIVED. IF ANY ADDITIONAL INFORMATION IS OBTAINED A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DATA WAS RETRIEVED FROM THE SURGEON' S OFFICE WHICH CONFIRMED THE PATIENT WAS DIAGNOSED WITH AN ANTERIOR CORTICAL CATARACT ON (B)(6) 2010. THE LENS REMAINS IMPLANTED. VA POST-OP 20/25, VA POST DIAGNOSIS 20/30 V AND THE PROGNOSIS IS GOOD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Male