FDAFDA · Food and drugs·Recall number Z-1368-2024
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
Published April 3, 2024 · Recall initiated: January 16, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Olympus Corporation of the Americas
- Distributor
- International distribution to the country of Japan.
- Lot
- UDI-DI: N/A All Lot Numbers
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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