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Open, Classified

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

FDA Recall Z-1673-2022 · Posted None

Recalling FirmOculus Optikgeraete GMBH
Recall StatusOpen, Classified
Product CodeMXK
Date Initiated2022-07-08
Product Quantity92 systems with affected software

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

Firm 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]

Root Cause

Software design

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K152311Pentacam AXLOculus Optikgerate GmbH · 2016-01-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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