Z-1368-2024Class II

InstaClear Lens Cleaner-indicated for use during routine diagnostic procedures and during endoscopic sinus...

Name: Z-1368-2024 InstaClear Lens Cleaner-indicated for use during routine diagnostic procedures and during endoscopic sinus...
Creator: Olympus Corporation of the Americas
Published: 2024-01-16
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2024-01-16 / Open, Classified / root cause: labeling and UDI

FDA source

Olympus Corporation of the Americas began a recall of InstaClear Lens Cleaner-indicated for use during routine diagnostic procedures and during endoscopic sinus surgery. Model Number: LCS1500UNOL LCS1800UNST... on 2024-01-16. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1368-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-01-16
Posted: 2024-03-22
Recalling firm: OLYMPUS Corporation of the Americas
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
Product code: EOB Nasopharyngoscope (Flexible Or Rigid)
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
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 102,279 units (OUS Only)
Distribution: International distribution to the country of Japan.
Product codes and lots: UDI-DI: N/A All Lot Numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1368-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1368-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-03	2024-03-22

Product code EOB

K152531Class IIInstaClear Lens CleanerGyrus Acmi, Inc. / cleared 2016-01-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)