BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 1994158 · Received February 16, 2011

    Report

    Report Number
    2023826-2011-00092
    Event Type
    Injury
    Date Received
    February 16, 2011
    Date of Event
    December 21, 2010
    Report Date
    January 21, 2011
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: METHOD: LENS WORK ORDER SEARCH, MEDICAL REVIEW. RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE WORK ORDER. MEDICAL REVIEW - SEVERAL CONDITIONS MAY ARISE FROM THIS EVENT (I.E. PUPILLARY BLOCK, MALIGNANT GLAUCOMA, INCREASED IOP ETC.). TO PREVENT ANY OF THESE COMPLICATIONS FROM OCCURRING, THE MANUFACTURER RECOMMENDS THAT THE LENS BE EXPLANTED AND/OR EXCHANGED WITH THE RIGHT SIZE ONCE THE SURGEON DETERMINES THAT THIS CONDITION MAY AFFECT THE OUTCOME OF THE PATIENT'S VISION. CONCLUSIONS (NO CONCLUSION CAN BE DRAWN): BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH AND MEDICAL REVIEW, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4), SURGICAL PROCEDURE, SECONDARY SURGERY, SURGICAL PROCEDURE, IRIDECTOMY, INTRAOCULAR PRESSURE RISE, PUPILLARY BLOCK, PARESIS, IRIS. (B)(4), EXPLANTED, LENS, VAULTING, EXCESSIVE, (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.0MM ICM120V4 IMPLANTABLE COLLAMER LENS IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2010. THE LENS WAS EXPLANTED ON (B)(6) 2010 DUE TO EXCESSIVE VAULTING. SUBSEQUENTLY, THE PATIENT EXPERIENCED ELEVATED IOP (PUPILLARY BLOCK), NARROWING OF THE ANGLE AND SHALLOWING OF THE ANTERIOR CHAMBER. A SURGICAL IRIDECTOMY WAS PERFORMED. PATIENT HAD IRIS PARESIS DUE TO INCREASE ON MEAN MYDRIASIS. THE REPORTER INDICATED THE CAUSE OF THE EVENT WAS DUE TO A BIG ICL WITH SMALL IRIDECTOMIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY ICM120V4

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention CARTRIDGE MODEL AND LOT NUMBER UNKNOWN| FOAM TIP PLUNGER MODEL AND LOT NUMBER UNKNOWN| INJECTOR MODEL AND LOT NUMBER UNKNOWN