International safety notice
During the power inspection during the manufacturing of the product, the lens power after swelling is determined from the dry state lens power. Although the calculation was used to determine suitability within the standard range, there was a difference between the calculated predicted value and the actual measured value after swelling. As a deviation was observed, there is a possibility that the lens power after swelling for some products may deviate from the standard. It turns out that there is. We will voluntarily recall the lot.
Japan / PMDA Recalls · JPN · Jun 17, 2024
Key facts
| Title | During the power inspection during the manufacturing of the product, the lens power after swelling is determined from the dry state lens power. Although the calculation was used to determine suitability within the standard range, there was a difference between the calculated predicted value and the actual measured value after swelling. As a deviation was observed, there is a possibility that the lens power after swelling for some products may deviate from the standard. It turns out that there is. We will voluntarily recall the lot. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Reusable colored contact lenses for vision correction Sales name: Aimy Super Soft II |
| Manufacturer | Tomey Contact Lens Co., Ltd. |
| Models | 42K000706, 07K001123, 07K003509, 23K000309, 14K001616, 35K002315, 07K003503, 28K004209, 0XK002626, 0XK003041, 17K001914, 12K004233 and 1672 more |
| Date | Jun 17, 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