BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 14365002 · Received May 11, 2022

    Report

    Report Number
    2023826-2022-01477
    Event Type
    Injury
    Date Received
    May 11, 2022
    Report Date
    April 11, 2022
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WEIGHT: UNK. ETHNICITY: UNK. RACE: UNK. DATE OF EVENT: UNK. EXPIRATION DATE UNK. IMPLANT DATE: UNK. EXPLANT DATE: UNK. DEVICE MANUFACTURE DATE: UNK. HEALTH IMPACT- CLINICAL CODE: (B)(4) PRECIPITATES; IRIS CHAFFING. HEALTH EFFECT IMPACT CODE: (B)(4) TOPICAL PREDNISOLONE ACETATE. CLAIM # (B)(4).

    Description of Event or Problem · 0

    A CASE REPORT FROM THE JOURNAL OF VITREORETINAL DISEASES WAS RECEIVED IN REGARD TO "CULTURE-NEGATIVE C ACNES ENDOPHTHALMITIS FOLLOWING IMPLANTATION OF A PHAKIC IMPLANTABLE COLLAMER LENS". THE CASE REPORT WAS ABOUT A 34-YEAR-OLD WOMAN WHO PRESENTED WITH CHRONIC UNILATERAL IRITIS, WITH PRECIPITATES 5 MONTHS AFTER BILATERAL IMPLANTABLE COLLAMER (ICL) IMPLANTATION IN THE LEFT EYE (OS). TREATMENT WITH TOPICAL PREDNISOLONE ACETATE WAS INITIALLY SUCCESSFUL BUT THE IRITIS RECURRED. THE PATIENT WAS REFERRED TO A UVEITIS SPECIALIST AT EIGHT MONTHS POSTOP, AND TESTS FOR UVEITIS HAD NEGATIVE FINDINGS. ULTRASOUND BIOMICROSCOPY SHOWED POSSIBLE CHAFFING OF THE IRIS BY THE ICL. AT 10 MONTHS AFTER THE INITIAL SURGERY, THE ICL WAS REMOVED. PATIENT CONTINUED TO DEVELOP WORSENING FLOATERS AND VA. ONE YEAR AFTER ICL PLACEMENT, PATIENT HAD 2+ VITRITIS WITH SMALL DEPOSITS ON POSTERIOR SURFACE OF NATURAL LENS. A DIAGNOSTIC VITRECTOMY WAS PERFORMED THAT WAS CULTURE NEGATIVE. TRIAL OF ORAL PREDNISONE RESULTED IN ONLY TRANSIENT IMPROVEMENT OF UVEITIS. A SECOND VITRECTOMY COMBINED WITH LENSECTOMY WAS PERFORMED. CULTURES HAD NEGATIVE FINDINGS, BUT BACTERIAL PCR TESTING WAS POSITIVE FOR C ACNES. TREATMENT WITH INTRAVITREAL VANCOMYCIN AND CEFTAZIDIME WAS ADMINISTERED. AT 3 MONTHS FOLLOW-UP, PATIENT HAD COMPLETE RESOLUTION OF OCULAR INFLAMMATION AND TREATMENTS DISCONTINUED. AT ONE-YEAR FOLLOW-UP PATIENT'S VISION WAS 20/20 WITH CORRECTION FOR APHAKIA. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2130857 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female Required Intervention