# FDA recall Z-0635-2018

> **Oculus Optikgeraete GMBH** · Class II · device recall initiated 2017-11-21.

## 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 for recall

The device software versions have an anomaly which may produce an erroneous marking for the quality specification value

## Distribution

US Distribution to the states of :  CA and FL.  There were no foreign/military/government accounts.

## Key facts

- **Recall number:** Z-0635-2018
- **Recalling firm:** Oculus Optikgeraete GMBH
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-11-21
- **Report date:** 2018-02-28
- **Termination date:** 2018-03-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Wetzlar, N/A, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0635-2018

## Citation

> AI Analytics. FDA recall Z-0635-2018. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/Z-0635-2018. Source: US FDA. Licensed CC0.

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