BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE COLLAMER LENS

    MDR report key: 12119274 · Received July 5, 2021

    Report

    Report Number
    2023826-2021-02282
    Event Type
    Injury
    Date Received
    July 5, 2021
    Date of Event
    November 12, 2020
    Report Date
    June 10, 2021
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    QCB
    UDI-DI
    00841542106658
    PMA / PMN Number
    P030016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H3 - DEVICE EVALUATION: LENS WAS RETURNED IN VIAL, IN LIQUID. VISIBLE INSPECTION FOUND NO VISIBLE DAMAGE ON LENS. CLAIM# : (B)(4).

    Additional Manufacturer Narrative · 0

    H6: DEVICE HISTORY RECORD (OHR) REVIEW: BASED ON THE RESULTS OF THE INVESTIGATION, ALL RELEASED DEVICES FROM THE ASSOCIATED WORK ORDER(S), INCLUDING THE SUSPECTED DEVICE; HAVE BEEN MANUFACTURED WITHIN ESTABLISHED PROCESS PARAMETERS; AND THERE IS NO INDICATION THAT THE MANUFACTURING AND PROCESSING OF THE DEVICE CONTRIBUTED TO THE COMPLAINT ISSUE. COMPLAINT# (B)(4).

    Additional Manufacturer Narrative · 1

    LENS WORK ORDER SEARCH-NO SIMILAR COMPLAINT TYPE EVENTS REPORTED FOR UNITS WITHIN THE SAME LOT. CLAIM# (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM TMICL12.6 IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT (OS) EYE ON (B)(6) 2020. THE SURGEON REPORTS LOW VAULT, LENS ROTATION, AND REFRACTIVE SURPRISE. THE CAUSE OF THE EVENT IS REPORTED AS OTHER: THE LENS HAS ROTATED OUT OF POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1011957 IMPLANTABLE COLLAMER LENS PHAKIC TORIC INTRAOCULAR LENS QCB STAAR SURGICAL COMPANY TMICL12.6 NA 00841542106658

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Male UNK.