International safety notice
For the product manufactured by a specific manufacturing unit from a foreign manufacturer, the weak principal meridian (having weak refractive power) on the intraocular lens It is confirmed that the product has an angular difference exceeding the internal standard between the toric axis mark (mark indicating the weak principal meridian) and the toric axis mark (mark indicating the weak principal meridian). Since we have received a report that the product has been approved by the manufacturing unit, we have received a report that the We will voluntarily recall the items. We will carry out patient monitoring.
Japan / PMDA Recalls · JPN · Dec 12, 2023
Key facts
| Title | For the product manufactured by a specific manufacturing unit from a foreign manufacturer, the weak principal meridian (having weak refractive power) on the intraocular lens It is confirmed that the product has an angular difference exceeding the internal standard between the toric axis mark (mark indicating the weak principal meridian) and the toric axis mark (mark indicating the weak principal meridian). Since we have received a report that the product has been approved by the manufacturing unit, we have received a report that the We will voluntarily recall the items. We will carry out patient monitoring. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Posterior chamber lens Sales name: Technis Toric Opti Blue |
| Manufacturer | AMO Japan Co., Ltd. |
| Models | 3474112107, 3474242107, 3474072107, 74102107, 3474252107, 3474332107, 3473932107, 3474132107, 3474312107, 3474262107, 3473902107, 3473912107 and 25 more |
| Date | Dec 12, 2023 |
| 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