Recall Z-1672-2022— Oculus Optikgeraete GMBH
Class II · Ongoing
Class II FDA medical device recall by Oculus Optikgeraete GMBH, initiated 2022-07-08. It names one FDA 510(k) clearance: K201724. Product: Pentacam AXL Wave REF 70020. Used to image the anterior segment of the eye.. Reason: Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs.
- Recalling firm
- Oculus Optikgeraete GMBH
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-07-08
- Firm location
- Wetzlar, Germany
510(k) clearances named in this recall
1 on FDA's recordK-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
Pentacam AXL Wave REF 70020. Used to image the anterior segment of the eye.
Reason for recall
Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs
Data sourced from openFDA. This site is unofficial and independent of the FDA.