Mani TROCAR Kit 23G S: Fluid Leakage Risk in Ophthalmic Surgery

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Recalling firmMani, Inc. - Kiyohara FacilityPark 8-3, Kiyoharakogyodanchi; Kiyoharakogyodanchi; Kiyoharakogyodanchi · Utsunomiya, N/A N/A

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Mani is recalling its TROCAR KIT 23G S surgical tool for eye procedures because the Luer connector may leak fluid or disconnect unexpectedly. This could lead to complications during delicate eye surgery.

Why it’s dangerous

The Luer connector parts have dimensions outside the required specifications. This can cause fluid leakage or unintended disconnection during surgery, potentially leading to complications in eye procedures.

Who’s affected

Ophthalmic surgeons and medical staff using the TROCAR KIT 23G S for eye surgery procedures. Those with the specific lot codes V180077300 (expiring 2020/10) or V200009500 (expiring 2022/03) are most at risk.

How to tell if you have this one

Check for the product name 'TROCAR KIT 23G S' used in eye surgery. Look for lot codes V180077300 (expiring 2020/10) or V200009500 (expiring 2022/03) on the packaging.

Brand
Mani
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Lot Code
Look for lot codes V180077300 (expiring 2020/10) or V200009500 (expiring 2022/03) on the packaging.

✎ GovInfoNow

Questions people ask

What is the specific model of the recalled product?

The recalled product is the MANI TROCAR KIT 23G S used in ophthalmic surgery.

What lot codes are affected?

Lot codes V180077300 (expiring 2020/10) and V200009500 (expiring 2022/03) are affected.

Is there a fix or remedy for this issue?

The recall record does not specify a remedy.

Take action

Contact Mani

We’ve drafted a message you can send Mani to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-0557-2021 — Mani Mani

Hello,

I own a Mani that is covered by recall Z-0557-2021 from Mani.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0557-2021 (October 27, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0557-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Mani, Inc. - Kiyohara Facility recalls MANI TROCAR KIT 23G S - Product Usage: for use in injecting perfusate or aspirating out intraocular materials during

Use caution until it’s fixed