Company: Oculus Optikgeraete GMBH
Date of Enforcement Report: 9/1/2022
Class II
PRODUCT
Pentacam AXL Wave REF 70020. Used to image the anterior segment of the eye.
Recall Number:
Z-1672-2022
REASON
Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs
RECALLING FIRM/MANUFACTURER
Oculus Optikgeraete GMBH; Voluntary. Firm initiated.
VOLUME OF PRODUCT IN COMMERCE
21 systems with affected software
DISTRIBUTION
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
