FDA Device

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

Hazard

Dimensions of the Luer connector parts out of specification, may cause leakage of fluid and unintended disconnection during use

What You Should Do

Remedy

MANI Inc. issued Voluntary Removal letter issued on 10/27/20 via email to the US Distributor stating reason for removal, health risk and action to take: request distributors to return the devices. If there are MANI TROCAR KIT and MANI INFUSION CANNULA in your stock and/or your customer's stock: Please write the returning Q'ty. in the list ,"Returned" If MANI TROCAR KIT and MANI INFUSION CANNULA are already used up : Please write the used Q'ty. in the list , "Used. Please send this sheet and relevant items if you have to our address below. Any costs/fees related to this return shipment should be charged to MANI FedEx account. MANI, INC. 8-3, Kiyohara Industrial Park, Utsunomiya, Tochigi, 321-3231, Japan

Products

MANI TROCAR KIT 23G S - Product Usage: for use in injecting perfusate or aspirating out intraocular materials during ophthalmic surgery, Ref: MTK 23S
Brand
Mani, Inc. Kiyohara Facility Park 8-3 Kiyoharakogyodanchi; Kiyoharakogyodanchi; Kiyoharakogyodanchi Utsunomiya Japan
UPC
Lot Codes: V180077300, Exp Date: 2020/10 and   V200009500, EXp Date: 2022/03

Units Affected

6 units (US)