Oculus Optikgeraete GMBH Munchholzhauser Str. 29 Wetzlar Germany Pentacam AXL Wave REF 70020. Used to image the anterior segment of the eye. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Pentacam AXL Wave REF 70020. Used to image the anterior segment of the eye.
Brand
Oculus Optikgeraete GMBH Munchholzhauser Str. 29 Wetzlar Germany
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Software version: 1.26r26 and 1.26r27 Model Number: 70020 UDI-DI Code: 04049584025357 Serial Numbers: 70020 0111 0201 70020 0211 0201 70020 0311 0211 70020 0711 1230 70020 1211 0201 70020 1321 1211 70020 2411 0211 70020 2911 1250 70020 3511 0211 70020 3801 0230 70020 4701 0210 70020 4811 1250 70020 5411 0211 70020 5701 0210 70020 6611 1230 70020 6621 1211 70020 7011 0201 70020 7511 1230 70020 8021 1290 70020 8701 0210 70020 9011 0201
Oculus Optikgeraete GMBH Munchholzhauser Str. 29 Wetzlar Germany is recalling Pentacam AXL Wave REF 70020. Used to image the anterior segment of the eye. due to Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs
Recommended Action
Per FDA guidance
On 07/08/2022, OCULUS GmbH issued an "Urgent safety information Corrective Action " Letter to its subsidiary OCULUS Inc via UPS express which identifies a software error in the software version 1.26r26 and 1.26r27 in the IOL calculator of the Pentacam software. Corrective measures to be taken: A software update to version 1.26r28 must be performed on all computers used and affected in connection with the Pentacam and additional workstations. Users should refrain from using the printout of the IOL calculator for affected installations until after the software update has been carried out. For questions or support - contact OCULUS Inc Service Team at 425-670-9977 or email service@oculususa.com or fsca@oculus.de
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
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, PR
Page updated: Jan 10, 2026