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    OCULUS Optikgeräte GmbH

    Manufacturer
    🇩🇪 Germany

    OCULUS OPTIKGERATE GMBH

    FDA registration
    OCULUS OPTIKGERATE GMBH·23 products·🇩🇪 Germany

    OCULUS PENTACAM

    FDA Adverse Event
    Malfunction ·OCULUS OPTIKGERATE GMBH·Product code MXK·November 7, 2025

    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.

    FDA Enforcement
    Class II ·Terminated·Oculus Optikgeraete GMBH·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 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.

    FDA Recall
    Terminated ·Oculus Optikgeraete GMBH Munchholzhauser Str. 29 Wetzlar Germany·Product code MXK·November 21, 2017

    OCULUS Optikgeräte GmbH

    Importer
    🇩🇪 Germany·6 Manufacturers