International safety notice

This product assumes that it will be used in applications where the blade part is subject to a load in the rotational direction, and the connection part between the blade part and the handle part is Although the design requires press processing to secure the rotation, there are products that are manufactured and shipped without press processing. Since this has been confirmed, we have decided to carry out a voluntary recall.

Japan / PMDA Recalls · JPN · Mar 18, 2024

Key facts

Title This product assumes that it will be used in applications where the blade part is subject to a load in the rotational direction, and the connection part between the blade part and the handle part is Although the design requires press processing to secure the rotation, there are products that are manufactured and shipped without press processing. Since this has been confirmed, we have decided to carry out a voluntary recall.
Regulator Japan / PMDA Recalls
Country JPN
Brand Common name: Single-use ophthalmic knife Sales name: Manny Ophthalmic Knife
Manufacturer Manny Co., Ltd.
Models K233006300, MND10
Date Mar 18, 2024
Regulator page info.pmda.go.jp

At a glance

  • No Recall
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About International device safety notices

Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.

Source: National medical device regulators (as listed), compiled by Orca1

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