FDA Device recall Z-1673-2022
Pentacam AXL REF 70100, 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 AXL REF 70100, 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-1673-2022 |
| 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 AXL REF 70100, 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: 70100 UDI-DI Code: 04049584012333 Serial Numbers: 70100 0301 5170…Software version: 1.26r26 and 1.26r27 Model Number: 70100 UDI-DI Code: 04049584012333 Serial Numbers: 70100 0301 5170 70100 0332 1280 70100 0351 7190 70100 0421 6101 70100 0461 7121 70100 0561 8130 70100 0641 7170 70100 0981 9120 70100 1032 1270 70100 1171 8180 70100 1291 9130 70100 1491 9140 70100 1551 7190 70100 1631 7140 70100 1632 2210 70100 1751 7190 70100 1802 0250 70100 1881 9120 70100 2181 8101 70100 2651 7190 70100 2731 7140 70100 2821 7110 70100 2912 1220 70100 3122 1240 70100 3141 7160 70100 3221 6190 70100 3222 1240 70100 3541 7160 70100 3561 8130 70100 3691 9160 70100 3701 6110 70100 3722 1270 70100 3881 9120 70100 3931 7150 70100 4012 0270 70100 4032 1270 70100 4502 0230 70100 4511 6170 70100 4922 1270 70100 4961 8170 70100 5032 1270 70100 5071 8180 70100 5141 7160 70100 5232 1280 70100 5311 6160 70100 5332 1290 70100 5441 7160 70100 5461 7121 70100 5621 6111 70100 5651 7190 70100 5661 8130 70100 5671 8101 70100 5981 9120 70100 6022 1220 70100 6032 1270 70100 6171 8180 7 |
|---|
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-1673-2022%22
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