InstaClear Lens Cleaner-indicated for use during routine diagnostic procedures and during endoscopic sinus surgery. Mod
Summary
The FDA issued a Class II for InstaClear Lens Cleaner-indicated for use during routine diagnostic procedures a by Olympus Corporation of the Americas. Reason: Japanese IFU version had slightly different language and illustrations from the English IFU, which could contribute to the tip and plate falling off. .
Details
Source
Device Recall
External ID
Z-1368-2024
Action Date
2024-04-03
Status
Ongoing
Category
device
Product Description
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
Lot/Code Info: UDI-DI: N/A All Lot Numbers
Quantity Affected: 102,279 units (OUS Only)
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-01-16
Company
Center Valley, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 163 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Olympus Corporation of the Americas has 334 FDA actions in our database, including 334 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Olympus Corporation of the Americas) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Olympus Corporation of the Americas have FDA actions?
Olympus Corporation of the Americas has 334 FDA actions in our database, including 334 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1368-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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