Z-1674-2022 Class II Ongoing
FDA device recall Z-1674-2022 was initiated by Oculus Optikgeraete GMBH on Jul 8, 2022 and is designated Class II. 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 The recall status is ongoing. Affected quantity: 19 systems with affected software.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 7, 2022
- Initiation Date
- Jul 8, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19 systems with affected software
Product Description
Pentacam HR REF 70900. Used to image the anterior segment of the eye.
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
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
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1674-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026