Oculus Optikgeraete GMBH recalls Pentacam AXL REF 70100, Pentacam HR REF 70900. Used to image the anterior segment of the eye.

Recall date

July 8, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1673-2022

FDA classification

Class II

Brand / firm

Oculus Optikgeraete GMBH

Sold / distributed

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

Why it was recalled

Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Pentacam AXL REF 70100, Pentacam HR REF 70900. Used to image the anterior segment of the eye.