Reported Sep 7, 2022 · Ongoing
Pentacam HR REF 70900. Used to image the anterior segment of the eye.
Oculus Optikgeraete GmbH
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: Oculus Optikgeraete GMBH · Munchholzhauser Str. 29 · Wetzlar · N/A
Is this the product you have?
- Pentacam HR REF 70900. Used to image the anterior segment of the eye.
- Lot codes and dates
- Software version1.26r26 and 1.26r27
- Model Number70900
- UDI-DI Code04049584000026
- Serial Numbers
7090005748160709000925024070900099522507090016648130709001995225070900345170607090037952250709003965127070900404170107090041722110709004795225070900623471507090075521160709007952118070900880461407090088133140709009142012170900969522507090097952250
- Amount recalled
- 19 systems with affected software
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs
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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