Endoscopic Lens Cleaner Recalled for Instruction Discrepancy Risk
Olympus recalls InstaClear Lens Cleaner devices due to inconsistencies between Japanese and English instruction manuals that could cause component separation during endoscopic procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device with potential for component separation during endoscopic procedures due to instruction manual inconsistencies. No injuries have been reported.
Plain-English summary
Olympus Corporation of the Americas is recalling InstaClear Lens Cleaner devices used during routine diagnostic endoscopic procedures and endoscopic sinus surgery. The recall affects 102,279 units distributed to Japan, covering multiple model numbers including LCS1500UNOL, LCS1800UNST, LCS4K00UNOL, LCS1530BTOL, and others.
The Japanese version of the product's instruction manual contained different language and illustrations compared to the English version. These inconsistencies could contribute to the tip and plate falling off during use. To ensure consistency globally, Olympus will update the Japanese instruction manual to align with the English version.
No injuries or illnesses related to this issue have been reported. The affected devices were distributed to Japan only.
The recalled product
- Product
- InstaClear Lens Cleaner-indicated for use during routine diagnostic procedures and during endoscopic sinus surgery. Model Number: LCS1500UNOL LCS1800UNST LCS4K00UNOL LCS1530BTOL LCS1830BTST LCS4K30BTOL LCS1530TPOL LCS1830TPST LCS4K30TPOL LCS1545BTOL LCS1845BTST…
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device
- Affected units
- 102,279
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: N/A All Lot Numbers
Distribution
Distribution scope not specified by the agency.
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