BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2041894 · Received March 30, 2011

    Report

    Report Number
    2023826-2011-00269
    Event Type
    Injury
    Date Received
    March 30, 2011
    Date of Event
    February 4, 2011
    Report Date
    March 4, 2011
    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

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - SECONDARY. (B)(4) - IOPR. (B)(4).

    Additional Manufacturer Narrative · 1

    MEDICAL REVIEW. THE SURGEON IMPLANTED AN ICM120V4 -17.0 IN THE OD EYE OF THE PATIENT ON 2011-(B)(6) AND NOTICED IN THE EARLY POST-OPERATIVE PERIOD ELEVATED IOP / PUPIL BLOCK DUE TO ONE OF THE PI WHICH WAS NOT WORKING PROPERLY. THIS WAS ASSOCIATED WITH SIGNIFICANT REDUCTION OF IRIDO-CORNEAL ANGLES. THE SURGEON PERFORMED A SECONDARY YAG ONE DAY AFTER IMPLANTATION, THIS REDUCED THE IOP. DURING THIS PROCEDURE BLEEDING OF IRIS VESSELS OCCURRED. TWO DAYS AFTER THIS EVENT THE IOP WAS AGAIN ELEVATED AND THE SURGEON DECIDED TO EXPLANT THE LENS. THE REMOVAL OF THE LENS WAS DIFFICULT SINCE THERE WAS INFLAMMATION AND THE LENS WAS VERY STICKY TO THE IRIS. THE PUPIL WAS STILL FIXED. AFTER REMOVAL THE SURGEON NOTICED A CORNEAL EDEMA, LENS OPACITY AND PIGMENT DISPERSION. THE SURGEON DISCOVERED THAT THE PATIENT HAD PREVIOUS HISTORY OF UVEITIS WHICH WAS NOT DISCLOSED DURING THE PREOPERATIVE EXAMINATION. THIS IS A LABELED CONTRAINDICATION OF THE IMPLANTABLE COLLAMER LENS. A WORK ORDER SEARCH COULD NOT BE PERFORMED BECAUSE NO SERIAL NUMBER WAS PROVIDED. THE LENS WAS NOT RETURNED FOR EVALUATION. A MEDICAL REVIEW WAS PERFORMED. TO PREVENT PUPIL BLOCK PERIPHERAL IRIDOTOMIES ARE REQUIRED FOR ICL IMPLANTATION. THIS CAN BE ACHIEVED BY MEANS OF LASER YAG PI OR SURGICALLY (INTRA-OPERATIVELY). IF THE PERIPHERAL IRIDOTOMIES ARE NOT SUFFICIENT TO ENSURE PROPER AQUEOUS FLOW, THE IOP RISES. ENLARGEMENT OF THE EXISTING IRIDOTOMY SITE OR OPENING OF A NEW ONE SHOULD RE-ESTABLISH FLOW AND RETURN IOP TO NORMAL LEVELS. A KNOWN COMPLICATION OF PERIPHERAL IRIDOTOMIES IS THE POTENTIAL FOR BLEEDING INTO THE ANTERIOR CHAMBER. THIS MAY TRANSIENTLY CLOG THE TRABECULAR MESHWORK AND INCREASE THE IOP. PROMPT MEDICAL TREATMENT WHEN BLEEDING OCCURS PREVENTS FURTHER EVENTS SUCH AS IOP RISE, PAS (PERIPHERAL ANTERIOR SYNECHIAS), ETC. UVEITIS MAY HAVE FLARED AFTER THE INTRAOCULAR PROCEDURE AND THIS MAY HAVE CONTRIBUTED TO CLOSURE OF THE PIS. UVEITIS MAY ALSO INCREASE STICKINESS OF THE IRIS TO SURROUNDING TISSUES AND IOL. (SYNECHIAE). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON INSERTED AN ICM120V4 12.0MM IMPLANTABLE COLLAMER LENS ON (B)(6) 2011 AND LENS OPACITY (ASCO) WAS NOTED ON (B)(6) 2011. THE INCISION WAS ENLARGED AND THE CATARACT WAS EXTRACTED. PUPILLARY BLOCK AND INFLAMMATION WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL CO. ICM120V4 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention