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Recall Observatory FDA recall evidence

Device 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 LCS4K45BTOL LCS1545TPOL LCS1845TPST LCS4K45TPOL LCS1570BTOL LCS1870BTST LCS4K70BTOL LCS1570TPOL LCS1870TPST LCS4K70TPOL

Z-1368-2024

January 16, 2024

Class II

Product summary

Firm
Olympus Corporation of the Americas
Event
Event 94067
Status
Ongoing
Classification
Class II
Quantity
102,279 units (OUS Only)
Official record key
device-enforcement:Z-1368-2024

Official wording

Reason: 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

Code information: UDI-DI: N/A All Lot Numbers

Distribution pattern: International distribution to the country of Japan.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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