BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE COLLAMER LENS

    MDR report key: 6213394 · Received December 29, 2016

    Report

    Report Number
    2023826-2016-01834
    Event Type
    Injury
    Date Received
    December 29, 2016
    Date of Event
    November 2, 2016
    Report Date
    November 30, 2016
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER IMPLANTATION, THE PATIENT ALSO EXPERIENCED HAZY VISION, HIGH IOP, AND SYNECHIA. (B)(4). INITIAL MDR DATE IS (B)(6) 2016. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    "THE LENS WAS EXPLANTED" IS CORRECTED TO " THE LENS WAS EXCHANGED FOR A SIMILAR LENS OF DIFFERENT DIOPTER ON (B)(6) 2017. REPORTER STATED THAT THE PATIENT WAS HAPPY. THE EXCHANGE RESOLVED THE PROBLEM. (B)(4). CORRECTED DATA: OUTCOMES ATTRIBUTED TO ADVERSE EVENT: IT IS CORRECTED FROM "OTHER SERIOUS" IN THE PREVIOUS SUPPLEMENTAL TO "REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/ DAMAGE". (B)(4).

    Additional Manufacturer Narrative · 1

    THE LENS WAS EXPLANTED. DEVICE EVALUATION: THE LENS WAS RETURNED DRY IN A LENS CASE/ VIAL. VISUAL INSPECTION FOUND THE LENS HAPTIC BENT. DIMENSIONAL AND FUNCTIONAL INSPECTION FOUND THE LENS TO BE WITHIN SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.1MM VICH12.1 IMPLANTABLE COLLAMER LENS, +3.0 DIOPTER, INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2016. AFTER IMPLANTATION, THE PATIENT EXPERIENCED REFRACTIVE SURPRISE, LENS OPACITY (ASCO), INFLAMMATION, AND DAY 1 PUPILLARY MEMBRANE. IN ADDITION, A SECONDARY INTERVENTION OF ENLARGEMENT/ADDITION OF PI USING YAG WAS PERFORMED. AS OF THE DATE OF MDR SUBMISSION, THE LENS REMAINS IMPLANTED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864599 IMPLANTABLE COLLAMER LENS PHAKIC INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY VICH12.1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other| R