Recall Z-0635-2018— Oculus Optikgeraete GMBH

Name: FDA recall Z-0635-2018
Creator: U.S. Food and Drug Administration
Published: 2017-11-21

Class II · Terminated

Class II FDA medical device recall by Oculus Optikgeraete GMBH, initiated 2017-11-21, terminated 2018-03-22. It names one FDA 510(k) clearance: K152311. 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.. Reason: The device software versions have an anomaly which may produce an erroneous marking for the quality specification value.

Recalling firm: Oculus Optikgeraete GMBH
Classification: Class II
Status: Terminated
Initiated: 2017-11-21
Terminated: 2018-03-22
Firm location: Wetzlar, N/A, Germany

510(k) clearances named in this recall

1 on FDA's record

K152311 — Pentacam AXLOculus Optikgerate GmbH·cleared 2016-01-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.