Oculus Optikgeraete GMBH: Medical Device Recall in 2022 - (Recall #: Z-1674-2022)

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 HR REF 70900. 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-1674-2022

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: 19 systems with affected software

Code Information:

Software version: 1.26r26 and 1.26r27 Model Number: 70900 UDI-DI Code: 04049584000026 Serial Numbers: 70900 0574 8160 70900 0925 0240 70900 0995 2250 70900 1664 8130 70900 1995 2250 70900 3451 7060 70900 3795 2250 70900 3965 1270 70900 4041 7010 70900 4172 2110 70900 4795 2250 70900 6234 7150 70900 7552 1160 70900 7952 1180 70900 8804 6140 70900 8813 3140 70900 9142 0121 70900 9695 2250 70900 9795 2250

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