Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported February 28, 2018
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 a
The device software versions have an anomaly which may produce an erroneous marking for the quality specification value
Oculus Optikgeraete Gmbh recalled OCULUS Pentacam AXL, Model 70100, software versions 1.21r01, 1.21r03, 1.21r11, and 1.21r1… - a moderate-severity action.
OCULUS Pentacam AXL, Model 70100, software versions 1.21r01, 1.21r03, 1.21r11, and 1.21r1… was recalled by Oculus Optikgeraete Gmbh in February 28, 2018. Reason: The device software versions have an anomaly which may produce an erroneous marking for the quality specifica…. Check the official notice for the remedy. Verify recall #Z-0635-2018 with the FDA Devices before acting.
The recall
Oculus Optikgeraete Gmbh issued this moderate-severity FDA Devices recall-The device software versions have an anomaly which may produce an erroneous marking for the quality specifica….
- Moderate
- severity level
- 83 units
- affected scope
- Class II
- classification
- February 28, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0635-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0635-2018) was formally reported on February 28, 2018, with the manufacturer initiating the action on November 21, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Oculus Optikgeraete Gmbh is listed as the recalling firm, operating out of Wetzlar, N/A. Federal records list the affected scope as 83 devices.
The documented reason for this recall is: The device software versions have an anomaly which may produce an erroneous marking for the quality specification value Distribution data in the federal record shows the product reached: US Distribution to the states of : CA and FL. There were no foreign/military/government accounts.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
83 devices
Related Recalls
6
3 from same agency
Product description
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
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0635-2018 |
| Date reported | February 28, 2018 |
| Date initiated | November 21, 2017 |
| Recalling firm | Oculus Optikgeraete Gmbh |
| Firm location | Wetzlar, N/A |
| Affected scope | 83 devices |
| Distribution | US Distribution to the states of : CA and FL. There were no foreign/military/government accounts. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0635-2018) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Oculus Optikgeraete Gmbh. Units affected: 83 devices.
Why was this product recalled? ▼
The device software versions have an anomaly which may produce an erroneous marking for the quality specification value
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 28, 2018. Severity: Moderate. Recall number: Z-0635-2018.
Where was the recalled product distributed? ▼
Distribution: US Distribution to the states of : CA and FL. There were no foreign/military/government accounts..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0635-2018) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported February 28, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.