Pentacam HR REF 70900. Used to image the anterior segment… recallZ-1674-2022 · 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-1674-2022
- Status
- Open, Classified
- Initiated by the company
- Jul 8, 2022
- Recalling firm
- Oculus Optikgeraete GMBH
- Quantity
- 19 systems with affected software
- Product code
- MXK
- FDA submissions
- K030719
- 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 HR REF 70900. Used to image the anterior segment of the eye.
Code information (models, lots, serial numbers)
Software version: 1.26r26 and 1.26r27 Model Number: 70900 UDI-DI Code: 04049584000026 Serial Numbers: 70900 0574 8160 70900 0925 0240 70900 0995 2250 70900 1664 8130 70900 1995 2250 70900 3451 7060 70900 3795 2250 70900 3965 1270 70900 4041 7010 70900 4172 2110 70900 4795 2250 70900 6234 7150 70900 7552 1160 70900 7952 1180 70900 8804 6140 70900 8813 3140 70900 9142 0121 70900 9695 2250 70900 9795 2250
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Pentacam HR 70900OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung · Device,Analysis,Anterior Segment1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 90661).
- Z-1672-2022 · Open, ClassifiedPentacam AXL Wave REF 70020. Used to image the anterior segment of the eye.
- Z-1673-2022 · Open, ClassifiedPentacam AXL REF 70100, Pentacam 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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