Pentacam AXL Wave REF 70020. Used to image the anterior segment of the eye.
Recall
- Recall Number
- Z-1672-2022
- Event Number
- 90661
- Firm
- Oculus Optikgeraete GMBH Munchholzhauser Str. 29 Wetzlar Germany
- FEI Number
- 3002807782
- Product Code
- MXK
- Status
- Open, Classified
- Root Cause
- Software design
- Initiated
- July 8, 2022
Description
Pentacam AXL Wave REF 70020. Used to image the anterior segment of the eye.
Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs
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 [email protected] or [email protected]
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
21 systems with affected software