BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTREPID AUTOSERT IOL HANDPIECE

    MDR report key: 4996333 · Received August 12, 2015

    Report

    Report Number
    2028159-2015-07565
    Event Type
    Injury
    Date Received
    August 12, 2015
    Date of Event
    July 1, 2015
    Report Date
    November 23, 2015
    Manufacturer
    ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER
    Product Code
    HQR
    PMA / PMN Number
    K112425
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CLINICAL ANALYST REVIEWED THE FILE AND STATED THE FOLLOWING: ¿THE CUSTOMER REPORTED THE INJECTOR DELIVERED THE LENS HEAVILY INTO THE BAG. THE CAPSULE OF THE EYE WAS DAMAGED. THE CUSTOMER NOTED ¿THE DOCTOR SOLVED IMMEDIATELY¿. IN THE SURGEON¿S OPINION IT IS UNKNOWN WHAT CAUSED OR CONTRIBUTED TO THE EVENT. HOWEVER, THE SURGEON DID INDICATE THAT THE PERFORMANCE OF THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. NO SURGICAL INTERVENTION WAS REQUIRED. THE STATUS OF THE PATIENT WAS NOTED AS RESOLVED. POSTERIOR CAPSULE (PC) TEAR IS A POTENTIAL CONSEQUENCE OF CATARACT EXTRACTION BY PHACOEMULSIFICATION. PREDISPOSITION TO PC TEAR OR ZONULAR DEHISCENCE CAN BE INFLUENCED BY MANY FACTORS INCLUDING, BUT NOT LIMITED TO, CONGENITAL POSTERIOR LENTICONUS, POSTERIOR SUB CAPSULAR (PSC) CATARACT, POOR VISIBILITY SECONDARY TO PATIENTS COMORBIDITY [I.E. DENSE ARCUS, PTERYGIUM, BAND KERATOPATHY, CORNEAL SCARS, INTERSTITIAL KERATITIS], POOR MICROSCOPE ILLUMINATION [RED REFLEX], ERGONOMIC OBSTACLES, LIMITED INTRAOCULAR WORKING SPACE, ABNORMALLY LONG OR SHORT AXIAL LENGTHS, PSEUDOEXFOLIATION, ZONULAR LAXITY, POOR DILATION, INTRAOPERATIVE FLOPPY IRIS SYNDROME (IFIS), DENSE CATARACTS, ASTEROID HYALOSIS, OR INADVERTENT PATIENT MOVEMENT. THE CONDITIONS THAT INCREASE THE RISK OF PC TEAR DURING PHACOEMULSIFICATION INCLUDE ERGONOMIC OBSTACLES, LIMITED INTRAOCULAR WORKING SPACE, POOR VISUALIZATION, INCREASED NUCLEAR SIZE AND DENSITY, WEAKENED ZONULE, A RADIAL TEAR IN THE CAPSULORHEXIS, AND AN INABILITY TO ROTATE THE NUCLEUS OR EPINUCLEUS. THESE CONDITIONS MAY ARISE EITHER BECAUSE OF THE OCULAR ANATOMY, OR BECAUSE OF SURGICAL TECHNIQUE. THERE IS NO EVIDENCE CONTAINED WITHIN THE REPORTED INFORMATION AT THIS TIME THAT INDICATES THAT THE DESIGN OR PERFORMANCE OF THE INJECTOR HAD ANY EFFECT ON THE INTEGRITY OF THE POSTERIOR CAPSULE. THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED CONCLUSIVELY.¿ NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED FROM THIS CUSTOMER. WITH NO ADDITIONAL, RELATED INFORMATION PROVIDED, THE CUSTOMERS REPORTED EVENT WAS NOT ABLE TO BE CONFIRMED. POSTERIOR CAPSULE TEAR IS AN ISSUE THAT IS OCCASIONALLY REPORTED WITH CATARACT SURGERY. HOWEVER, A REVIEW OF THE COMPLAINT TRENDS SHOWS THAT THE FREQUENCY REPORTED IS WITHIN KNOWN LEVELS FOR THIS EVENT. A ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT THE INTRAOCULAR LENS INJECTOR DELIVERED THE INTRAOCULAR LENS HEAVILY, DAMAGING THE CAPSULAR BAG. THE SURGEON REPAIRED THE CAPSULE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531487 INTREPID AUTOSERT IOL HANDPIECE APPARATUS, CAUTERY, RADIOFREQUENCY, AC-POWERED HQR ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention