Wetzlar, N/A, Germany
Oculus Optikgeraete GMBH recalls
3 recalls recorded since 2018, most recently on 8 August 2023. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)2
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 8 August 2023
- Reason
- Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements.
- Distribution
- US Nationwide distribution in the states of CA, FL, MA, MN, NY, NC, OH, PA, TX, VA, WA. OUS: Not Provided
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2483-2023, Z-2484-2023, Z-2482-2023
- Oculus Pentacam AXL , Ref 70100, CE 0123
- Oculus Myopia Master , Ref 68100, CE 0123
- Oculus Pentacam AXL Wave, Ref 70020, CE 0123
Ongoing Class II Medical devices
- Recall started
- 8 July 2022
- Reason
- Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs
- Distribution
- U.S.: AL, AR, AZ, CAQ, CO, CT, FL, GA, HI, IA, ID, IL, KS, KY, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NY, OH, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, WA, WI, and WY O.U.S.: N/A
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1673-2022, Z-1672-2022, Z-1674-2022
- Pentacam AXL REF 70100, Pentacam HR REF 70900. Used to image the anterior segment of the eye.
- Pentacam AXL Wave REF 70020. Used to image the anterior segment of the eye.
- Pentacam HR REF 70900. Used to image the anterior segment of the eye.
Terminated Class II Medical devices
- Recall started
- 21 November 2017
- Terminated
- 22 March 2018
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0635-2018
- 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 a
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.