FDA Device recall Z-1674-2022
Pentacam HR REF 70900
- FDA Device
- Class II
- ongoing
- Published 2022-09-07
On 2022-09-07 the FDA classified a Class II recall of Pentacam HR REF 70900 by Oculus Optikgeraete, citing due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1674-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-07-08 |
| Published | 2022-09-07 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Oculus Optikgeraete |
| Distribution | AL, AR, AZ, CO, CT, FL, GA, HI, IA, ID, IL, KS, KY, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NY, OH, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WY |
Product
Pentacam HR REF 70900. Used to image the anterior segment of the eye.
Reason
Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs
Identifiers
| code_info | Software version: 1.26r26 and 1.26r27 Model Number: 70900 UDI-DI Code: 04049584000026 Serial Numbers: 70900 0574 8160…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1674-2022%22
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