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

FDA device recall Z-1368-2024 · posted 2024-03-22 · Open, Classified

Recall details

Recalling firm

Olympus Corporation of the Americas

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

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

EOB

Quantity affected

102,279 units (OUS Only)

Distribution

International distribution to the country of Japan.

Date initiated

2024-01-16

Date posted

2024-03-22

Location

Center Valley, PA

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