OCULUS Pentacam AXL — Class II medical device recall Z-0635-2018
Terminated recall by Oculus Optikgeraete GMBH, reported 2018-02-28, distributed in CA, FL. The device software versions have an anomaly which may produce an erroneous marking for the quality specificat
| Recall number | Z-0635-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Oculus Optikgeraete GMBH, Wetzlar, N/A, Germany |
| Recall initiated | 2017-11-21 |
| Classified | 2018-02-16 |
| Reported by FDA | 2018-02-28 |
| Terminated | 2018-03-22 |
| Distributed | CA, FL |
| Quantity | 83 devices |
| Reason classes | software |
| Serial numbers | 0021, 0301, 0311, 0331, 0401, 0421, 0641, 0831, 1021, 1101, 1541, 1631, 1731, 1831, 1901, 2211, 2221, 2231, 2241, 2511, 2641, 2731, 2801, 2821, 2931 and 75 more |
| Model numbers | 70100 |
Product
OCULUS Pentacam AXL, Model 70100, software versions 1.21r01, 1.21r03, 1.21r11, and 1.21r13. The firm name on the label is OCULUS Optikgerate GmbH, Made in Germany. The Pentacam AXL is designed to take photos of the anterior segment of the eye, which includes the cornea, pupil, anterior chamber, and lens of the eye, to evaluate corneal shape, analyze condition of the lens (opaque crystalline lens), analyze the anterior chamber angle, analyze anterior chamber depth, analyze the volume of the anterior chamber, analyze anterior or posterior cortical opacity, analyze the location of cataracts (nuclear, sub capsular and/or cortical), using cross slit imaging with densitometry, corneal thickness, axial length, and white-to-white distance. The Pentacam AXL also performs calculations to assist physicians in determining the power of the intraocular lens for implantation.
Reason for recall
The device software versions have an anomaly which may produce an erroneous marking for the quality specification value
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-0635-2018. 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.