Pentacam AXL Wave REF 70020 — Class II medical device recall Z-1672-2022
Ongoing recall by Oculus Optikgeraete GMBH, reported 2022-09-07, distributed in AL, AR, AZ, CO, CT, FL, GA, HI…. Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and inci
| Recall number | Z-1672-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Oculus Optikgeraete GMBH, Wetzlar, Germany |
| Recall initiated | 2022-07-08 |
| Classified | 2022-09-01 |
| Reported by FDA | 2022-09-07 |
| Distributed | AL, AR, AZ, CO, CT, FL, GA, HI, IA, ID, IL, KS, KY, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NY, OH, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WY |
| Quantity | 21 systems |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 04049584025357 |
| Serial numbers | 0111, 0201, 0210, 0211, 0230, 0311, 0711, 1211, 1230, 1250, 1290, 1321, 2411, 2911, 3511, 3801, 4701, 4811, 5411, 5701, 6611, 6621, 70020, 7011, 7511 and 3 more |
| Model numbers | 70020 |
Product
Pentacam AXL Wave REF 70020. Used to image the anterior segment of the eye.
Reason for recall
Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1672-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.