Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Pentacam HR REF 70900. Used to image the anterior segment of the eye. Recalled by Oculus Optikgeraete GMBH Due to Due to a software issue, IOL calculator printout...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Oculus Optikgeraete GMBH directly.
Affected Products
Pentacam HR REF 70900. Used to image the anterior segment of the eye.
Quantity: 19 systems with affected software
Why Was This Recalled?
Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs
Where Was This Sold?
This product was distributed to 36 states: AL, AZ, AR, CO, CT, FL, GA, HI, ID, IL, IA, KS, KY, ME, MD, MI, MN, MS, MO, NE, NH, NJ, NM, NY, NC, OH, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY
About Oculus Optikgeraete GMBH
Oculus Optikgeraete GMBH has 7 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report