Recall archive / FDA device enforcement
Pentacam AXL Wave REF 70020. Used to image the anterior segment of the eye. — FDA record Z-1672-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jul 8, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Pentacam AXL Wave REF 70020. Used to image the anterior segment of the eye.
- Reason
- Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs
- Classification
- Class II
- Recalling firm
- Oculus Optikgeraete GMBH
- Quantity
- 21 systems with affected software
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1672-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
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
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Sep 7, 2022
- Recall initiation date
- Jul 8, 2022
- Center classification date
- Sep 1, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.