BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 3181609 · Received June 21, 2013

    Report

    Report Number
    2648035-2013-00254
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 28, 2013
    Report Date
    May 28, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS (IOL) WAS RETURNED TO THE MANUFACTURER. VISUAL INSPECTION SHOWED THE LENS HAD ONE DISTORTED HAPTIC AND APPEARS TO HAVE EVIDENCE OF OPHTHALMIC VISCOELASTIC ON IT.ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. (B)(4): PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    (B)(4). PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    MANUFACTURER REPORT NUMBER SHOULD HAVE BEEN (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PHACOEMULSIFICATION THE ANTERIOR CAPSULE WAS KNICKED. THE DOCTOR DID NOT NOTICE THIS UNTIL HE BEGAN TO INSERT THE INTRAOCULAR LENS (IOL). HE DECIDED TO REMOVE THE IOL AND REPLACE IT WITH A THREE PIECE LENS. TO REMOVE THE LENS THE ORIGINAL INCISION HAD TO BE ENLARGED. A VITRECTOMY WAS NOT REQUIRED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282007 TECNIS TORIC IOLS HQL ABBOTT MEDICAL OPTICS ZCT150

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention