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Oculus Optikgeraete GMBH recalls Pentacam AXL Wave REF 70020. Used to image the anterior segment of the eye.
Recalled September 7, 2022 · FDA recall Z-1672-2022 · Oculus Optikgeraete
Hazard
Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs · FDA Class II
Units
21 systems with affected software
Sold at
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
Description
Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs
Product
Pentacam AXL Wave REF 70020. Used to image the anterior segment of the eye.
Manufacturer(s)
Oculus Optikgeraete GMBH
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →