Oculus Optikgeraete GMBH recalls Pentacam AXL REF 70100, Pentacam HR REF 70900. Used to image the anterior segment of the eye.
Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs
Read the official notice →- Date
- 2022-09-07
- Country
- United States
- Brand
- Oculus Optikgeraete
- Product
- Pentacam AXL REF 70100, Pentacam HR REF 70900. Used to image the anterior segment of the eye.
- Classification
- Class II
- Units
- U.S.: AL, AR, AZ, CAQ, CO, CT, FL, GA, HI, IA, ID, IL, KS, KY, MD, ME, MI, MN,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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