CLASS II ONGOING Device recall · Reported 7 Sep 2022 · FDA Enforcement Report

Pentacam AXL recalled by Oculus Optikgeraete

Oculus Optikgeraete is recalling Pentacam AXL, distributed in 37 states. The recall was initiated on 8 Jul 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSoftware 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 70100 6332 1290 70100 6421 6101 70100 6451 7190 70100 6631 7140 70100 6651 7190 70100 6751 7111 70100 6821 7110 70100 7511 6170 70100 7631 7140 70100 7781 9120 70100 7831 7150 70100 7861 8170 70100 8021 6190 70100 8121 6190 70100 8212 0290 70100 8332 1290 70100 8511 6170 70100 8512 0211 70100 8611 6170 70100 8731 7150 70100 8791 9170 70100 8822 1270 70100 8891 9170 70100 9081 8101 70100 9132 1280 70100 9171 8180 70100 9221 6101 70100 9231 7130 70100 9332 1290 70100 9361 7121 70100 9471 8101 70100 9822 1270 70100 9881 9120 70100 9911 6190 70100 9912 1220 70100 9931 7150

Quantity recalled92 systems with affected software

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1673-2022
FDA event ID: 90661
Recalling firm: Oculus Optikgeraete, Wetzlar
Classification: Class II
Status: Ongoing
Recall initiated: 8 Jul 2022
FDA classified: 1 Sep 2022
Reported: 7 Sep 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

8 Jul 2022	Recall initiated by company
1 Sep 2022	Classified by FDA	+55 days
7 Sep 2022	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Pentacam AXL REF 70100, Pentacam HR REF 70900. Used to image the anterior segment of the eye.

Where it was distributed

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

Alabama Arkansas Arizona Colorado Connecticut Florida Georgia Hawaii Iowa Idaho Illinois Kansas Kentucky Maryland Maine Michigan Minnesota Missouri Mississippi North Carolina

Questions about this recall

Is Pentacam AXL recalled?

Yes. Oculus Optikgeraete recalled Pentacam AXL on 8 Jul 2022. The recall is Class II and its status is Ongoing. Recall number Z-1673-2022.

Why was it recalled?

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

Which lots are affected?

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 70100 6332 1290 70100 6421 6101 70100 6451 7190 70100 6631 7140 70100 6651 7190 70100 6751 7111 70100 6821 7110 70100 7511 6170 70100 7631 7140 70100 7781 9120 70100 7831 7150 70100 7861 8170 70100 8021 6190 70100 8121 6190 70100 8212 0290 70100 8332 1290 70100 8511 6170 70100 8512 0211 70100 8611 6170 70100 8731 7150 70100 8791 9170 70100 8822 1270 70100 8891 9170 70100 9081 8101 70100 9132 1280 70100 9171 8180 70100 9221 6101 70100 9231 7130 70100 9332 1290 70100 9361 7121 70100 9471 8101 70100 9822 1270 70100 9881 9120 70100 9911 6190 70100 9912 1220 70100 9931 7150

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Oculus Optikgeraete

All 7

Reported	Class	Recall	Company	Reason	Where
6 Sep 2023Device	CLASS II	Oculus Pentacam AXL Wave recalled by Oculus Optikgeraete	Oculus Optikgeraete	Lead & Heavy Metals	Nationwide
6 Sep 2023Device	CLASS II	Oculus Myopia Master recalled by Oculus Optikgeraete	Oculus Optikgeraete	Lead & Heavy Metals	Nationwide
6 Sep 2023Device	CLASS II	Oculus Pentacam AXL recalled by Oculus Optikgeraete	Oculus Optikgeraete	Lead & Heavy Metals	Nationwide
7 Sep 2022Device	CLASS II	Pentacam HR recalled by Oculus Optikgeraete	Oculus Optikgeraete	Device Malfunction	37 states
7 Sep 2022Device	CLASS II	Pentacam AXL Wave recalled by Oculus Optikgeraete	Oculus Optikgeraete	Device Malfunction	37 states

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide