Device recall: OCT-Camera 211 01 A1, Running software iOCT-Control 3 v1.4
Class II FDA enforcement event 89176. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
Malfunction of the automatic laser beam shut-off, the OCT unit might not recognize whether the laser beam is safely switched off
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 3 Nov 2021. The firm address in the FDA record is in Mason, OH. FDA put the recall in Class II. FDA event 89176 has 2 product records. The first FDA enforcement report date is 19 Jan 2022. The record gives the status Ongoing.
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.
US Nationwide distribution in the states of OH, IN.
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
2 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0477-2022 | OCT-Camera 211 01 A1, Running software iOCT-Control 3 v1.4 | 2 devices quarantined in US | Class II | Ongoing | 19 Jan 2022 |
| Z-0478-2022 | OCT-Camera 211 01 A3; Running software iOCT-Control 3 v1.4 | 3 | Class II | Ongoing | 19 Jan 2022 |
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 2021
- 900
- Share of these events in Class II
- 89%
- Product records in this event
- 2Median of the firm: 1
- Events of the firm on the register
- 6
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 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 |
| 17 Aug 2012 | Octopus 101 Perimeter; PeriTrend Software Analysis A perimeter is a device intended to determine the extent of the perip | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-0477-2022The 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 89176. https://recallregister.com/fda/ii/89176/. 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:
US Nationwide distribution in the states of OH, IN.
- What quantity of product is in FDA event 89176?
- The event has 2 product records. The first record gives this quantity:
2 devices quarantined in US
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2021 have the same class?
- 89% of the 900 device events that started in 2021 are in Class II.