BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 2121067 · Received June 9, 2011

    Report

    Report Number
    3008772169-2011-00002
    Event Type
    Injury
    Date Received
    June 9, 2011
    Date of Event
    May 10, 2011
    Report Date
    May 10, 2011
    Manufacturer
    ALCON - LENSX LASERS, INC.
    Product Code
    OOE
    PMA / PMN Number
    K101626
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY FIELD SVC ENGINEER WAS PRESENT ON SITE FOR SURGERY SUPPORT AT THE TIME OF THE EVENT. THE LASER SYSTEM WAS SUBJECTED TO A THOROUGH INVESTIGATION AT THE END OF THE SURGERY DAY. THE INVESTIGATION REVEALED THAT THERE WERE NO PROBLEMS FOUND, NO ERROR MESSAGES GENERATED DURING THE DAY, AND THE DEVICE WAS OPERATING WITHIN SPECIFICATIONS. THERE WERE NO DEVICE MALFUNCTIONS REPORTED AND ACCORDING TO THE SURGEON, THE SYSTEM WAS FUNCTIONING AS INTENDED. A LITERATURE REVIEW WAS CONDUCTED AND THE CASE DESCRIBED IN THIS REPORT IS CONSISTENT WITH REPORTS OF INTRAOPERATIVE CAPSULAR BLOCK SYNDROME IN WHICH SUBLUXATION OF THE LENS OCCURS FOLLOWING CAPSULORHEXIS AND HYDRODISSECTION. THIS IS THOUGHT TO BE DUE TO OVER-DISTENSION OF THE POSTERIOR CAPSULE IF INJECTED FLUID DOES NOT HAVE FREE TRAVEL AROUND THE LENS AND OUT THROUGH THE CAPSULOTOMY. CONCLUSIONS: POSTERIOR CAPSULE RUPTURE OCCURRING DURING HYDRODISSECTION RESULTED IN DISLOCATED LENS AND REQUIRED SECONDARY SURGICAL INTERVENTION WITH POSTERIOR VITRECTOMY. NO DEVICE MALFUNCTIONS OCCURRED AND THE LASER SYSTEM WAS OPERATING AS INTENDED WITHIN SPECIFICATIONS. WHILE THE PT'S PREEXISTING DENSE NUCLEAR SCLEROTIC CATARACT IS A PREDISPOSING FACTOR FOR INTRAOPERATIVE CAPSULAR BLOCK SYNDROME THAT CAN RESULT IN POSTERIOR CAPSULE RUPTURE DURING HYDRODISSECTION, THE PRESENCE OF A GAS BUBBLE POSTERIOR TO THE CRYSTALLINE LENS AND DEEP FURROW MAY BE A POTENTIAL CONTRIBUTING FACTOR IN PREVENTING EGRESS OF INJECTED FLUID OUT OF THE CAPSULOTOMY. PERFORMING HYDRODISSECTION AFTER NUCLEAR FRACTURE HAS BEEN REPORTED TO REDUCE CAPSULAR BAG DISTENSION. (B)(4).

    Description of Event or Problem · 1

    THE SURGEON REPORTS PERFORMING CATARACT SURGERY WITH USE OF THE LENSX LASER SYSTEM FOR CREATION OF THE CAPSULOTOMY, LENS FRAGMENTATION, AND CORNEAL INCISIONS. THE LENSX PROCEDURE WAS UNEVENTFUL AND THERE WERE NO ERRORS OR MALFUNCTIONS EXPERIENCED. THE PT WAS THEN TRANSPORTED TO THE OPERATING ROOM FOR COMPLETION OF THE CATARACT SURGERY AND THE CAPSULOTOMY WAS REMOVED NORMALLY WITH NO EVIDENCE OF A TEAR. DURING HYDRODISSECTION, WRINKLING/MOVEMENT OF LENS CAPSULE/IRIS SUGGESTIVE OF POSTERIOR CAPSULAR TEAR WAS NOTED. DURING ATTEMPTED PHACOEMULSIFICATION, THE LENS DISLOCATED AND THE EYE WAS CLOSED. THE PT WAS REFERRED TO A VITREORETINAL SURGEON FOR A POSTERIOR VITRECTOMY. DURING THE VITRECTOMY, THE SURGEON OBSERVED A TEAR IN THE ANTERIOR CAPSULE THAT EXTENDED INTO THE POSTERIOR CAPSULE. THE REMAINDER OF THE LENS NUCLEUS AND CORTEX WAS REMOVED USING VITREORETINAL INSTRUMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON - LENSX LASERS, INC. 550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention