Olympus Corporation of the Americas: InstaClear Lens Cleaner-indicated for use during routine diagnostic procedures and during endoscopic sinus surgery. Model Number: LCS1500UNOL LCS1800UNST LCS4K00UN

Hazard

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

Details from the source

Reason for recall: 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 Distribution: International distribution to the country of Japan. Quantity: 102,279 units (OUS Only) Lot/code info: UDI-DI: N/A All Lot Numbers

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.