Z-1674-2022Class II

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

Name: Z-1674-2022 Pentacam HR REF 70900. 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 HR REF 70900. 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-1674-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-07-08
Posted: 2022-09-02
Recalling firm: Oculus Optikgerate GmbH
Product: Pentacam HR REF 70900. 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: 19 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: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1674-2022
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

K030719Class IIPentacam Scheimpflug CameraOculus Optikgerate GmbH / cleared 2003-09-16

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)