International safety notice

We are currently manufacturing and selling ophthalmic surgery laser lens treatment pack (certification number 227AHBZX00031) 000) (hereinafter referred to as ``Treatment Pack''), the legal label did not mention ``single use''. It has become clear.

Japan / PMDA Recalls · JPN · Dec 16, 2024

Key facts

Title We are currently manufacturing and selling ophthalmic surgery laser lens treatment pack (certification number 227AHBZX00031) 000) (hereinafter referred to as ``Treatment Pack''), the legal label did not mention ``single use''. It has become clear.
Regulator Japan / PMDA Recalls
Country JPN
Brand Common name: Laser lens for ophthalmic surgery Sales name: Treatment pack
Manufacturer Carl Zeiss Meditec Co., Ltd.
Models JM23000008, JS23000054
Date Dec 16, 2024
Regulator page info.pmda.go.jp

At a glance

  • No Recall
  • No Field safety notice

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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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