BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AKREOS MICRO INCISION LENS

    MDR report key: 1940386 · Received December 20, 2010

    Report

    Report Number
    1119279-2010-00134
    Event Type
    Injury
    Date Received
    December 20, 2010
    Date of Event
    August 23, 2010
    Report Date
    October 6, 2010
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    HQL
    PMA / PMN Number
    P060022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DAMAGED LENS WAS RETURNED TO B&L AND SUBJECTED TO VISUAL INSPECTION. RESULTS REVEALED THAT ONE HAPTIC WAS TORN OFF AND IS MISSING. THE CONDITION OF THE LENS IS CONSISTENT WITH LENSES THAT HAVE BEEN REMOVED FROM THE EYE. ADDITIONALLY, THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS THAT RELATE TO THE REPORTED ISSUE. ACCORDING TO THE PHYSICIAN THE MOST LIKELY CAUSE OF THE IOL DAMAGE WAS A LOADING ISSUE. (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTS PERFORMING CATARACT SURGERY WITH ATTEMPTED IMPLANTATION OF THE (B)(4) INTRAOCULAR LENS USING A VISCOJECT 2.2 DELIVERY DEVICE. DURING INSERTION OF THE IOL THE PHYSICIAN OBSERVED THAT THE TRAILING HAPTIC WAS TORN. INTERVENTION WAS PERFORMED IN ORDER TO ENLARGE THE INCISION AND REMOVE AND REPLACE THE LENS WITH A SECOND (B)(4) IOL. ACCORDING TO THE PHYSICIAN THE PT'S VISUAL OUTCOME IS GOOD. REFERENCE MDR 1119279-2010-00135.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AKREOS MICRO INCISION LENS INTRAOCULAR LENS HQL BAUSCH & LOMB, INC. MI60LUS 1933431

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention VISCOJECT 2.2 DELIVERY DEVICE (B&L)