Reported Apr 3, 2024 · Ongoing
InstaClear Lens Cleaner-indicated for use during routine diagnostic procedures and during endoscopic sinus surgery.…
Olympus Corporation of the Americas
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Olympus Corporation of the Americas · 3500 Corporate Pkwy · Center Valley, PA · 18034-8229
Is this the product you have?
- InstaClear Lens Cleaner-indicated for use during routine diagnostic procedures and during endoscopic sinus surgery
- Model Number
LCS1500UNOLLCS1800UNSTLCS4K00UNOLLCS1530BTOLLCS1830BTSTLCS4K30BTOLLCS1530TPOLLCS1830TPSTLCS4K30TPOLLCS1545BTOLLCS1845BTSTLCS4K45BTOLLCS1545TPOLLCS1845TPSTLCS4K45TPOLLCS1570BTOLLCS1870BTSTLCS4K70BTOLLCS1570TPOLLCS1870TPSTLCS4K70TPOL
- Lot codes and dates
- UDI-DIN/A All Lot Numbers
- Amount recalled
- 102,279 units (OUS Only)
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Why it was recalled
Japanese IFU version had slightly different language and illustrations from the English IFU, which could contribute to the tip and plate falling off. In order to maintain consistency globally, the Japanese IFU will be updated to reflect the instructions in the English IFU
This product could cause temporary or reversible health problems — stop using it.
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