Pentacam AXL Wave REF 70020. Used to image the anterior… recallZ-1672-2022 · Oculus Optikgeraete GMBH · initiated Jul 8, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Oculus Optikgeraete GMBH or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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
FDA root cause category: Software design
What the company is doing
On 07/08/2022, OCULUS GmbH issued an "Urgent safety information Corrective Action " Letter to its subsidiary OCULUS Inc via UPS express which identifies a software error in the software version 1.26r26 and 1.26r27 in the IOL calculator of the Pentacam software. Corrective measures to be taken: A software update to version 1.26r28 must be performed on all computers used and affected in connection with the Pentacam and additional workstations. Users should refrain from using the printout of the IOL calculator for affected installations until after the software update has been carried out. For questions or support - contact OCULUS Inc Service Team at 425-670-9977 or email [email protected] or [email protected]
Recall details
- Recall number
- Z-1672-2022
- Status
- Open, Classified
- Initiated by the company
- Jul 8, 2022
- Recalling firm
- Oculus Optikgeraete GMBH
- Quantity
- 21 systems with affected software
- Product code
- MXK
- FDA submissions
- K201724
- Distribution
- U.S.: AL, AR, AZ, CAQ, CO, CT, FL, GA, HI, IA, ID, IL, KS, KY, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NY, OH, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, WA, WI, and WY O.U.S.: N/A
Product description
Pentacam AXL Wave REF 70020. Used to image the anterior segment of the eye.
Code information (models, lots, serial numbers)
Software version: 1.26r26 and 1.26r27 Model Number: 70020 UDI-DI Code: 04049584025357 Serial Numbers: 70020 0111 0201 70020 0211 0201 70020 0311 0211 70020 0711 1230 70020 1211 0201 70020 1321 1211 70020 2411 0211 70020 2911 1250 70020 3511 0211 70020 3801 0230 70020 4701 0210 70020 4811 1250 70020 5411 0211 70020 5701 0210 70020 6611 1230 70020 6621 1211 70020 7011 0201 70020 7511 1230 70020 8021 1290 70020 8701 0210 70020 9011 0201
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Pentacam AXL Wave 70020OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung · Device, Analysis, Anterior Segment2 recalls0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 90661).
- Z-1673-2022 · Open, ClassifiedPentacam AXL REF 70100, Pentacam HR REF 70900. Used to image the anterior segment of the eye.
- Z-1674-2022 · Open, ClassifiedPentacam HR REF 70900. Used to image the anterior segment of the eye.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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