Recall Z-1674-2022 ยท MXK Device, Analysis, Anterior Segment
Oculus Optikgeraete GMBH
Pentacam HR REF 70900. Used to image the anterior segment of the eye.
| Date | Jul 8, 2022 |
| Status | Open, Classified |
| Reason | Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs |
| Root cause | Software design |
| Action | 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 |
| Quantity | 19 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030719 | PENTACAM SCHEIMPFLUG CAMERA Oculus Optikgerate GmbH, Sep 16, 2003 |