—#206240

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

FDA product code: EOB — Nasopharyngoscope (Flexible Or Rigid)
Device class: Class 2
Medical specialty: Ear, Nose, Throat
510(k) numbers: K152531
Affected lot / code info: UDI-DI: N/A All Lot Numbers

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Olympus issued Urgent Medical Device Corrective Action letter on 1/16/24 to the Distributor-OLYMPUS MEDICAL SYSTEMS CORP LOGITE Tokyo, Japan for distribution to their consignees. Letter states reason for recall, health risk and action to take: Our records indicate that your facility has purchased one or more of the affected InstaClear Sheaths. Olympus requests you to take the following actions: 1. Inspect your inventory and identify any devices with the model names specified above. Please check all areas of the hospital to determine if any of these devices remain in inventory. Add a copy of the enclosed addendum with your remaining inventory. You may continue to use the products, but this should be done in accordance with the attached labeling addendum. 2. Carefully read the content of this Medical Device Correction Action as well as the attached labelling Addendum . 3. Ensure all current and future personnel, including clinical staff, are completely knowledgeable and thoroughly aware of the contents. The Addendum provides the updated instructions for proper setup of the InstaClear Sheath. 4. Olympus requests that you acknowledge receipt of this letter [local facility method/contact]. 5. If you have further distributed this product, identify your customers, forward them this notification, and appropriately document your notification process. Actions to be taken by the company: Olympus will update the labelling to include the improved instructions regarding proper installation and setup of the InstaClear Sheath. Additionally, your local Olympus contact will reach out to schedule an onsite educational training on setup of the InstaClear device.

Recalling firm

Firm: Olympus Corporation of the Americas
Address: 3500 Corporate Pkwy, Center Valley, Pennsylvania 18034-8229

Distribution

Distribution pattern: International distribution to the country of Japan.

Timeline

Recall initiated: 2024-01-16
Posted by FDA: 2024-03-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #206240. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.