Events

Recall of Octopus 101 Perimeter

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
    63011
  • Event Risk Class
    Class 2
  • Event Number
    Z-2411-2012
  • Event Initiated Date
    2012-08-17
  • Event Date Posted
    2012-09-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-05-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112266
  • 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
    Perimeter, automatic, ac-powered - Product Code HPT
  • Reason
    The firm recalled the device after learning of a possible deviation in the stimulus luminance of the perimeter octopus 101.
  • Action
    The firm, HAAG-STREIT USA, Inc., sent a "Field Safety Notice 2012-01/01" dated August 10, 2012 via certified mail or onsite visit to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to make all users of the product and relevant personnel aware of this Field Safety Notice; forward a copy to third parties, if affected product has been passed on; keep this notice at least until the completion of the corrective measure, and complete and return the enclosed Confirmation of Receipt Form via fax to: 513-229-3867 or scanned and emailed to : fieldsafetynotice@haag-streit-usa.com. If you have any questions, call 513-336-7255.

Device

Octopus 101 Perimeter
  • Model / Serial
    Model Octopus 101. SN: 119, 136, 165, 166, 221, 222, 225, 236, 243, 273, 277, 279, 370, 371, 392, 507, 541, 553, 570, 602, 603, 611, 620, 622, 661, 667, 668, 687, 690, 726, 741, 744, 794, 796, 1054, 1214, 1275, 1276, 1277, 1313, 1322, 1326, 1380, 1402, 1404, 1413, 1414, 1436, 1437, 1459, 1460, 1489, 1490, 1491, 1492, 1560, 1561, 1607, 1608, 1625, 1626, 1706, 1710, 1852
  • Product Classification
    Ophthalmic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) including states of: AR, CA, CT, FL, GA, IA, IL, LA, MA, MI, MN, MS, NJ, NV, NY, OH, OR, PA, SC, SD, WA, WI, and WV; and to the countries of Jamaica, Puerto Rico, and Mexico.
  • Product Description
    Octopus 101 Perimeter; PeriTrend Software Analysis || A perimeter is a device intended to determine the extent of the peripheral visual field of a patient. The device projects light on various points of a curved surface, and the patient indicates whether he or she sees the light.
  • 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