International safety notice
Our company manufactures and sells daily disposable soft contact lenses "Seed 1dayPure EDOF (32 pieces and 8 pieces) For some products of ``Seed 1dayPure UP'' (brand name: SEED 1dayPure UP), the display value of the apex refractive power (power) is -8.50D/Hi. After investigating the quality information, we found that the -5.50D/Hi lens may have been contaminated. As a result of the investigation, it was confirmed that a part of the mold was incorrectly installed during the production of the affected lot. Therefore, we have decided to voluntarily recall the lot.
Japan / PMDA Recalls · JPN · Jun 10, 2024
Key facts
| Title | Our company manufactures and sells daily disposable soft contact lenses "Seed 1dayPure EDOF (32 pieces and 8 pieces) For some products of ``Seed 1dayPure UP'' (brand name: SEED 1dayPure UP), the display value of the apex refractive power (power) is -8.50D/Hi. After investigating the quality information, we found that the -5.50D/Hi lens may have been contaminated. As a result of the investigation, it was confirmed that a part of the mold was incorrectly installed during the production of the affected lot. Therefore, we have decided to voluntarily recall the lot. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Single-use vision correction colored contact lenses Sales name: Seed 1dayPure UP |
| Manufacturer | Seed Co., Ltd. |
| Models | B143121733, C143121733 |
| Date | Jun 10, 2024 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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