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Recall Observatory FDA recall evidence

Device product

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

Z-0557-2021

October 27, 2020

Class II

Product summary

Firm
Mani, Inc. - Kiyohara Facility
Event
Event 86873
Status
Terminated
Classification
Class II
Quantity
6 units (US)
Official record key
device-enforcement:Z-0557-2021

Official wording

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

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

Distribution pattern: US Nationwide distribution in the state of MO.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    out of specification