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Recall

Class II — Haag-Streit USA Inc

Recalling firmHAAG-STREIT HOLDING
Registered facilityView this company's 5 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusTerminated
ReasonThe firm recalled the device after learning of a possible deviation in the stimulus luminance of the Perimeter OCTOPUS 101.
ProductOctopus 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.
Quantity64 units
DistributionWorldwide 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.
Initiated2012-08-17
Classified2012-09-20
Terminated2015-05-29
Recall numberZ-2411-2012
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Haag-Streit USA Inc (Z-2411-2012).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/63011/

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