Reported Sep 7, 2022 · Ongoing
Pentacam AXL Wave REF 70020. 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 Wave REF 70020. Used to image the anterior segment of the eye.
- Lot codes and dates
- Software version1.26r26 and 1.26r27
- Model Number70020
- UDI-DI Code04049584025357
- Serial Numbers
63 of 63 codes
70020011102017002002110201700200311021170020071112307002012110201700201321121170020241102117002029111250700203511021170020380102307002047010210700204811125070020541102117002057010210700206611123070020662112117002070110201700207511123070020802112907002087010210
- Amount recalled
- 21 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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