Z-1672-2022Class II

Pentacam AXL Wave REF 70020. Used to image the anterior segment of the eye

Name: Z-1672-2022 Pentacam AXL Wave REF 70020. Used to image the anterior segment of the eye
Creator: Oculus Optikgeraete GMBH
Published: 2022-07-08
License: https://open.fda.gov/license/

Oculus Optikgerate GmbH / initiated 2022-07-08 / Open, Classified / root cause: software

FDA source

Oculus Optikgeraete GMBH began a recall of Pentacam AXL Wave REF 70020. Used to image the anterior segment of the eye on 2022-07-08. FDA classified it as Class II and gives the reason as "Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1672-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-07-08
Posted: 2022-09-02
Recalling firm: Oculus Optikgerate GmbH
Product: Pentacam AXL Wave REF 70020. Used to image the anterior segment of the eye.
Product code: MXK Device, Analysis, Anterior Segment
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
Root cause tag: software
FDA root cause: Software design
Action: On 07/08/2022, OCULUS GmbH issued an "Urgent safety information Corrective Action " Letter to its subsidiary OCULUS Inc via UPS express which identifies a software error in the software version 1.26r26 and 1.26r27 in the IOL calculator of the Pentacam software. Corrective measures to be taken: A software update to version 1.26r28 must be performed on all computers used and affected in connection with the Pentacam and additional workstations. Users should refrain from using the printout of the IOL calculator for affected installations until after the software update has been carried out. For questions or support - contact OCULUS Inc Service Team at 425-670-9977 or email [email protected] or [email protected]
Quantity in commerce: 21 systems with affected software
Distribution: 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
Product codes and lots: Software version: 1.26r26 and 1.26r27 Model Number: 70020 UDI-DI Code: 04049584025357 Serial Numbers: 70020 0111 0201 70020 0211 0201 70020 0311 0211 70020 0711 1230 70020 1211 0201 70020 1321 1211 70020 2411 0211 70020 2911 1250 70020 3511 0211 70020 3801 0230 70020 4701 0210 70020 4811 1250 70020 5411 0211 70020 5701 0210 70020 6611 1230 70020 6621 1211 70020 7011 0201 70020 7511 1230 70020 8021 1290 70020 8701 0210 70020 9011 0201

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1672-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1672-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-07	2022-09-01
Z-1673-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-07	2022-09-01
Z-1674-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-07	2022-09-01

Product code MXK

K201724Class IIPentacam AXL WaveOculus Optikgerate GmbH / cleared 2020-10-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)