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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Mani, Inc. - Kiyohara Facility: Dimensions of the Luer connector parts out of specification, may cause leakage of fluid and unintended disconnection during use

Agency Publication Date: December 10, 2020
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Affected Products

Product: MANI TROCAR KIT 23G S - Product Usage: for use in injecting perfusate or aspirating out intraocular materials during ophthalmic surgery, Ref: MTK 23S

Lot Codes: V180077300, Exp Date: 2020/10 and V200009500, EXp Date: 2022/03

Lot Numbers:
Codes
Product: MANI Infusion Cannula 23G S - Product Usage: for use in injecting perfusate or aspirating out intraocular materials during ophthalmic surgery Ref: MTC 23S

Lot Codes: V180082900, Exp. Date: 2020/11 and V190000100, Exp Date: 2020/12

Lot Numbers:
Codes

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 86873
Status: Resolved
Manufacturer: Mani, Inc. - Kiyohara Facility
Manufactured In: Japan
Units Affected: 2 products (6 units (US); 60 units (US))

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.