Reported Jan 19, 2022 · Ongoing
OCT-Camera 211 01 A1, Running software iOCT-Control 3 v1.4
Haag-Streit USA Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Haag-Streit USA Inc · 3535 Kings Mills Rd · Mason, OH · 45040-2303
Is this the product you have?
OCT-Camera 211 01 A1Running software iOCT-Control 3 v1.4
- Lot codes and dates
Serial no. 00050023
- Amount recalled
- 2 devices quarantined in US
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Malfunction of the automatic laser beam shut-off, the OCT unit might not recognize whether the laser beam is safely switched off
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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