Device recall: Octopus 101 Perimeter; PeriTrend Software Analysis A perimeter is a device intended to determine the extent of the…
Class II FDA enforcement event 63011. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
The firm recalled the device after learning of a possible deviation in the stimulus luminance of the Perimeter OCTOPUS 101.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Haag-Streit USA Inc started this device recall on 17 Aug 2012. The firm address in the FDA record is in Mason, OH. FDA put the recall in Class II. FDA event 63011 has 1 product record. The first FDA enforcement report date is 26 Sep 2012. The record gives the status Terminated, with the termination date 29 May 2015.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
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…
Recalling firm
Haag-Streit USA Inc, Mason, OH.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2411-2012 | 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. | 64 units | Class II | Terminated | 26 Sep 2012 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2012
- 823
- Share of these events in Class II
- 88%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 6
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 3 Nov 2021 | OCT-Camera 211 01 A1, Running software iOCT-Control 3 v1.4 | Device | Class II | 2 |
| 15 Apr 2021 | Eyesuite 9.3.1 software, LENSTAR, MODEL LS900: ac-powered slit-lamp biomicroscope. | Device | Class II | 1 |
| 20 Nov 2020 | Haag Streit Surgical Floor stands FS 2-11 (Ref no. 615H511) and FS 2-15 (Ref no. 615H515) in combination with the operat | Device | Class II | 1 |
| 31 Jul 2019 | HS Hi-R NEO 900 Reference # 657 820 Serial # from 101 Product Usage: A wide range of surgical interventions are made pos | Device | Class II | 3 |
| 5 Jan 2017 | EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra Ocular Lenses (IOLs). | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-2411-2012The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 63011. https://recallregister.com/fda/ii/63011/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this 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…
- What quantity of product is in FDA event 63011?
- The FDA record gives this quantity:
64 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2012 have the same class?
- 88% of the 823 device events that started in 2012 are in Class II.