Recall record at a glance
| Official record | Z-0635-2018 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Oculus Optikgeraete GMBH |
| Report date | Feb 28, 2018 |
| Recall initiation date | Nov 21, 2017 |
| Quantity | 83 devices |
| Location | Wetzlar, N/A, Germany |
Official 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.
Why the product was recalled
The device software versions have an anomaly which may produce an erroneous marking for the quality specification value
Distribution information
US Distribution to the states of : CA and FL. There were no foreign/military/government accounts.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: E-Mail.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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