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Oculus Optikgeraete GMBH recalls OCULUS Pentacam AXL, Model 70100, software versions 1.21r01, 1.21r03, 1.21r11, and 1.21r13. The firm name on the label
Recalled February 28, 2018 · FDA recall Z-0635-2018 · Oculus Optikgeraete
Hazard
The device software versions have an anomaly which may produce an erroneous marking for the quality specification value · FDA Class II
Units
83 devices
Sold at
US Distribution to the states of : CA and FL. There were no foreign/military/government accounts.
Description
The device software versions have an anomaly which may produce an erroneous marking for the quality specification value
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.
Manufacturer(s)
Oculus Optikgeraete GMBH
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →