Olympus Corporation of the Americas is recalling 102,279 units of InstaClear Lens Cleaner, a device used to maintain visibility during diagnostic and sinus surgeries. The recall was initiated because the Japanese version of the instructions for use (IFU) contains language and illustrations that differ from the English version, which could lead to parts of the device falling off during a procedure. No specific injuries were reported, but the manufacturer is updating the instructions to ensure global consistency and safety. If you use these devices, you should contact Olympus to receive the updated guidance.
Discrepancies in the Japanese instructions could lead to the tip and plate of the lens cleaner falling off during surgery. If these components detach inside a patient, it could cause surgical delays or internal injury.
Instruction manual update
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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