Events

Recall of Device Recall Lenstar LS 900

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Haag-Streit USA Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    55857
  • Event Risk Class
    Class 2
  • Event Number
    Z-1897-2010
  • Event Initiated Date
    2010-05-19
  • Event Date Posted
    2010-06-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92075
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Device, measuring, lens radius, ophthalmic - Product Code HLF
  • Reason
    During the creation of the lenstar ls 900 software, the ability to perform a manual adjustment of the retinal thickness measurement was not disabled for products targeted for us distribution. the current software installed allows the user to manually alter the retinal thickness measurement, which could modify the automatic axial eye length measurement resulting in the selection of an incorrect in.
  • Action
    HAAG - Streit USA, Inc. issued notification letters to their customers informing them of the problem. They instructed their customer to refrain from adjusting the gates for the measurement of retinal thickness until after the system has been updated. For further information, contact HAAG - Streit USA, Inc. at 1-513-336-7255.

Device

Device Recall Lenstar LS 900
  • Model / Serial
    SERIAL Numbers: 223, 224, 225, 284, 285, 316, 317, 319, 320, 322, 323, 324, 325, 327, 330, 331, 332, 333, 364, 365, 366, 368, 369, 377, 378, 379, 381, 384, 385, 386, 405, 407, 408, 409, 411, 412, 413, 415, 416, 452, 454, 460, 461, 490 and 494.
  • Product Classification
    Ophthalmic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- Including AL, AZ, CA, FL, ID, KY, LA, MA, MI, MN, MO, NC, NJ, NY, OH, OR, PA, SC, VA, VT, WA and WV.
  • Product Description
    Lenstar LS 900, Biomicroscope, Slit-Lamp, AC-powered. HAAG-STREIT AG, Switzerland. || Used for obtaining ocular measurements and performing calculations to assist in determination of the appropriate power and type of Intraocular Lens for implantation after removal of the natural crystalline lens following cataract removal.
  • Manufacturer
    Haag-Streit USA Inc

Manufacturer

Haag-Streit USA Inc
  • Manufacturer Address
    Haag-Streit USA Inc, 3535 Kings Mills Rd, Mason OH 45040
  • Manufacturer Parent Company (2017)
    Metall Zug Ag
  • Source
    USFDA