CLASS II ONGOING Device recall · Reported 16 Mar 2022 · FDA Enforcement Report

Cirrus Hd-oct recalled by Carl Zeiss Meditec

Carl Zeiss Meditec is recalling Cirrus Hd-oct, distributed nationwide in the US. The recall was initiated on 14 Jan 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll instrument serial numbers running running software versions 11.5, 11.5.1 and 11.5.2. with ONH Angiography 4.5x4.5mm Scan

Quantity recalled1,272 devices

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-0723-2022
FDA event ID: 89524
Recalling firm: Carl Zeiss Meditec, Dublin, CA
Classification: Class II
Status: Ongoing
Recall initiated: 14 Jan 2022
FDA classified: 4 Mar 2022
Reported: 16 Mar 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

14 Jan 2022	Recall initiated by company
4 Mar 2022	Classified by FDA	+49 days
16 Mar 2022	Published in enforcement report	+12 days

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

Reason for recall

Optic nerve head angiography scan to be turned off due to its distribution without pre-market clearance.

Product as listed by the FDA

CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex

Where it was distributed

U.S Nationwide Distribution.: OH, CA, IN, AR, IA, LA, WI, OK, IL, OR, AL, KY, WY, WA, MN, NE, PA, SD, AZ, PR, TN, GA, FL, DE, NY, NH, TX, MS, MA, NV, UT, WV, ME, CO, AK, NM, KS, MO, MI, MD, ID, CT, NJ, MT, NC, VA, HI, VT, ND, SC, DC, RI

Nationwide Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts

Questions about this recall

Why was it recalled?

Optic nerve head angiography scan to be turned off due to its distribution without pre-market clearance.

Which lots are affected?

All instrument serial numbers running running software versions 11.5, 11.5.1 and 11.5.2. with ONH Angiography 4.5x4.5mm Scan

Where was it sold?

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 26 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 Carl Zeiss Meditec

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8 Jul 2026Device	CLASS II	Zeiss Intrabeam Spherical Applicator recalled by Carl Zeiss Meditec AG	Carl Zeiss Meditec	Other	Nationwide
4 May 2022Device	CLASS II	Zeiss miLOOP Lens Fragmentation Device recalled by Carl Zeiss Meditec AG	Carl Zeiss Meditec	Other	32 states
18 Aug 2021Device	CLASS II	Chassis Label - "Cirrus Hd-oct Rx-Only" Product Label recalled	Carl Zeiss Meditec	Device Malfunction	52 states
24 Feb 2021Device	CLASS II	IOLMaster recalled by Carl Zeiss Meditec AG	Carl Zeiss Meditec	Device Malfunction	39 states
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