OCULUS Pentacam AXL, Model 70100, software versions 1.21r01, 1.21r03, 1.21r11, and 1.21r13. The ...
FDA Device Recall #Z-0635-2018 — Class II — November 21, 2017
Recall Summary
| Recall Number | Z-0635-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 21, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Oculus Optikgeraete GMBH |
| Location | Wetzlar, N/A |
| Product Type | Devices |
| Quantity | 83 devices |
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
Distribution Pattern
US Distribution to the states of : CA and FL. There were no foreign/military/government accounts.
Lot / Code Information
Serial numbers: 70100 0021 6190, 70100 0301 5170, 70100 0311 6150, 70100 0331 7130, 70100 0401 5101, 70100 0421 6101, 70100 0641 7170, 70100 0831 7150, 70100 1021 6190, 70100 1101 5170, 70100 1541 7170, 70100 1631 7140, 70100 1731 7140, 70100 1831 7150, 70100 1901 6130, 70100 2211 6150, 70100 2221 6190, 70100 2231 7130, 70100 2241 7160, 70100 2511 6170, 70100 2641 7170, 70100 2731 7140, 70100 2801 6130, 70100 2821 7110, 70100 2931 7150, 70100 3221 6190, 70100 3701 6110, 70100 3731 7140, 70100 3931 7150, 70100 4041 7160, 70100 4211 6150, 70100 4231 7130, 70100 4401 5121, 70100 4511 6170, 70100 4711 6170, 70100 4831 7150, 70100 4931 7150, 70100 5311 6160, 70100 5531 7140, 70100 5611 6170, 70100 5621 6111, 70100 5831 7150, 70100 5931 7150, 70100 6101 5170, 70100 6221 6101, 70100 6231 7130, 70100 6331 7130, 70100 6401 5121, 70100 6421 6101, 70100 6631 7140, 70100 6801 6130, 70100 6811 6190, 70100 6821 7110, 70100 7041 7160, 70100 7221 6101, 70100 7401 5121, 70100 7511 6170, 70100 7531 7140, 70100 7631 7140, 70100 7731 7150, 70100 7831 7150, 70100 7931 7150, 70100 8121 6190, 70100 8141 7160, 70100 8511 6170, 70100 8531 7140, 70100 8611 6170, 70100 8631 7140, 70100 8721 7110, 70100 8731 7150, 70100 9041 7160, 70100 9221 6101, 70100 9231 7130, 70100 9301 5101, 70100 9411 6160, 70100 9521 6111, 70100 9711 6190, 70100 9731 7150, 70100 9911 6190, 70100 9931 7150, 70100 7411 6160, 70100 8021 6190, and 70100 4531 7140.
Other Recalls from Oculus Optikgeraete GMBH
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2483-2023 | Class II | Oculus Pentacam AXL , Ref 70100, CE 0123 | Aug 8, 2023 |
| Z-2484-2023 | Class II | Oculus Myopia Master , Ref 68100, CE 0123 | Aug 8, 2023 |
| Z-2482-2023 | Class II | Oculus Pentacam AXL Wave, Ref 70020, CE 0123 | Aug 8, 2023 |
| Z-1673-2022 | Class II | Pentacam AXL REF 70100, Pentacam HR REF 7090... | Jul 8, 2022 |
| Z-1672-2022 | Class II | Pentacam AXL Wave REF 70020. Used to image the... | Jul 8, 2022 |
Frequently Asked Questions
A software recall means the device's embedded software or firmware has a defect that could affect its performance or safety. Many software recalls are corrected through firmware updates that can be applied without physically replacing the device. For implantable devices, the update may be delivered wirelessly during a routine clinic visit. For external devices, the manufacturer may provide updated software files or replacement units. Contact your healthcare provider to determine whether your specific device and software version are affected and what action is recommended.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.