CLASS II ONGOING Device recall · Reported 6 Sep 2023 · FDA Enforcement Report

Oculus Pentacam AXL Wave recalled by Oculus Optikgeraete

Oculus Optikgeraete is recalling Oculus Pentacam AXL Wave, distributed nationwide in the US. The recall was initiated on 8 Aug 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI; (01) 04049584025357

Quantity recalled143 units

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-2482-2023
FDA event ID: 92847
Recalling firm: Oculus Optikgeraete, Wetzlar, N/A
Classification: Class II
Status: Ongoing
Recall initiated: 8 Aug 2023
FDA classified: 30 Aug 2023
Reported: 6 Sep 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Lead & Heavy Metals
Device type: Other Medical Devices

Timeline

8 Aug 2023	Recall initiated by company
30 Aug 2023	Classified by FDA	+22 days
6 Sep 2023	Published in enforcement report	+7 days

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

Reason for recall

Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements.

Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.

Product as listed by the FDA

Oculus Pentacam AXL Wave, Ref 70020, CE 0123

Where it was distributed

US Nationwide distribution in the states of CA, FL, MA, MN, NY, NC, OH, PA, TX, VA, WA. OUS: Not Provided

Nationwide California Florida Massachusetts Minnesota North Carolina New York Ohio Pennsylvania Texas Virginia Washington

Questions about this recall

Is Oculus Pentacam AXL Wave recalled?

Yes. Oculus Optikgeraete recalled Oculus Pentacam AXL Wave on 8 Aug 2023. The recall is Class II and its status is Ongoing. Recall number Z-2482-2023.

Why was it recalled?

Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements.

Which lots are affected?

UDI-DI; (01) 04049584025357

Where was it sold?

US Nationwide distribution in the states of CA, FL, MA, MN, NY, NC, OH, PA, TX, VA, WA. OUS: Not Provided

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 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
7 Sep 2022Device	CLASS II	Pentacam AXL recalled by Oculus Optikgeraete	Oculus Optikgeraete	Device Malfunction	37 states

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