Reported Sep 7, 2022 · Ongoing
Pentacam AXL REF 70100, 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 AXL REF 70100, Pentacam HR REF 70900. Used to image the anterior segment of the eye.
- Lot codes and dates
- Software version1.26r26 and 1.26r27
- Model Number70100
- UDI-DI Code04049584012333
- Serial Numbers
276 of 276 codes
70100030151707010003321280701000351719070100042161017010004617121701000561813070100064171707010009819120701001032127070100117181807010012919130701001491914070100155171907010016317140701001632221070100175171907010018020250701001881912070100218181017010026517190
- Amount recalled
- 92 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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