FDA-Device2022-09-07Class II
Pentacam AXL REF 70100, Pentacam HR REF 70900. Used to image the anterior segment of the eye.
Oculus Optikgeraete GMBH
Hazard
Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs
Sold states
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
Affected count
92 systems with affected software
Manufactured in
Munchholzhauser Str. 29, Wetzlar, Germany
Products
Pentacam AXL REF 70100, Pentacam HR REF 70900. Used to image the anterior segment of the eye.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1673-2022Don't want to check this manually?
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