International safety notice

This time, between two types of display standards for product packages (FT_41.5/TP_-1.50/DIA_10.6, FT_42.0/TP_-2.00/DIA_10.6) It has come to light that some products were incorrectly packaged and shipped. We have determined that there is a high level of risk and have decided to voluntarily recall the affected lots that have already been shipped.

Japan / PMDA Recalls · JPN · Jul 20, 2022

Key facts

Title This time, between two types of display standards for product packages (FT_41.5/TP_-1.50/DIA_10.6, FT_42.0/TP_-2.00/DIA_10.6) It has come to light that some products were incorrectly packaged and shipped. We have determined that there is a high level of risk and have decided to voluntarily recall the affected lots that have already been shipped.
Regulator Japan / PMDA Recalls
Country JPN
Brand Common name: Corneal correction contact lenses Sales name: Breath O Collect
Manufacturer Seed Co., Ltd.
Models 12142A1563, 12142A0643, 12142A1553, 12142A0663, 12142A1543, 12142A0653
Date Jul 20, 2022
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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