BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 7873772 · Received September 13, 2018

    Report

    Report Number
    2023826-2018-01364
    Event Type
    Injury
    Date Received
    September 13, 2018
    Report Date
    August 16, 2016
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    UDI-DI
    00841542103008
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WORK ORDER SEARCH: NO SIMILAR COMPLAINT WAS REPORTED FOR UNITS WITHIN THE SAME LOT. (B)(4).

    Additional Manufacturer Narrative · 1

    THE REPORTER INDICATED THE SURGEON IMPLANTED A12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -9.00 DIOPTER, ON (B)(6) 2016. THE LENS WAS REPORTED AS HAVING A SHALLOW VAULT. THE PATIENT RETURNED FOR A POST-OP VISIT A COUPLE OF WEEKS AGO WITH WORSENING VISION AND A LOT OF HAZE. THE PATIENT HAD ANTERIOR SUBCAPSULAR CATARACTS OU, OD IS WORSE THAN OS. OD IS CORRECTABLE TO 20/25 AND OS IS ONLY SUPERIOR SO NOT SENSITIVE TO CATARACT QUITE YET. THE PATIENT IS NOT HAPPY WITH HER VISION AND IS BEING MONITORED. THE LENS REMAINS IMPLANTED. SEE MFR. REPORT # 2023826-2018-01363 FOR FELLOW EYE. CLAIM # (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THE SURGEON IMPLANTED A12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -10.5 DIOPTER, ON (B)(6) 2016. THE LENS WAS REPORTED AS HAVING A SHALLOW VAULT. THE PATIENT RETURNED FOR A POST-OP VISIT A COUPLE OF WEEKS AGO WITH WORSENING VISION AND A LOT OF HAZE. THE PATIENT HAD ANTERIOR SUBCAPSULAR CATARACTS OU, OD IS WORSE THAN OS. OD IS CORRECTABLE TO 20/25 AND OS IS ONLY SUPERIOR SO NOT SENSITIVE TO CATARACT QUITE YET. THE PATIENT IS NOT HAPPY WITH HER VISION AND IS BEING MONITORED. THE LENS REMAINS IMPLANTED. SEE MFR. REPORT # 2023826-2018-01363 FOR FELLOW EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715472 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY MICL12.6 NA 00841542103008

    Patients

    Seq Age Sex Outcome Treatment
    1 Other CARTRIDGE MODEL SFC-45 - LOT NUMBER UNK| FOAM TIP PLUNGER MODEL FTP - LOT NUMBER UNK| INJECTOR MODEL MSI-PF - LOT NUMBER UNK