Oculus Optikgeraete GMBH: Medical Device Recall in 2022 - (Recall #: Z-1672-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Pentacam AXL Wave REF 70020. Used to image the anterior segment of the eye.

Product Classification:

Class II

Date Initiated: July 8, 2022

Date Posted: September 7, 2022

Recall Number: Z-1672-2022

Event ID: 90661

Reason for Recall:

Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs

Status: Ongoing

Product Quantity: 21 systems with affected software

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated