International safety notice
Recently, the Japan Medical Devices Agency (Independent Administrative Agency) has issued a minor change notification (irrigation/suction tube) dated February 17, 2017 regarding the product in question. It has been pointed out that the change in raw materials for Thank you very much. We will voluntarily recall the lots of products that still have their expiry date after the change.
Japan / PMDA Recalls · JPN · Jun 16, 2021
Key facts
| Title | Recently, the Japan Medical Devices Agency (Independent Administrative Agency) has issued a minor change notification (irrigation/suction tube) dated February 17, 2017 regarding the product in question. It has been pointed out that the change in raw materials for Thank you very much. We will voluntarily recall the lots of products that still have their expiry date after the change. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Cataract and vitrectomy device Brand name: (1) Phaco Disposable Pack II (Irrigation suction tube for Sovereign Compact: OPO61) (2) White Star Signature (Signature Disposable Pack I/II: OPO70/71) |
| Manufacturer | AMO Japan Co., Ltd. |
| Models | 60166644, 60215073, 60198257, 60138795, 60209329, 60232147, 60159447, 60197308, 60222426, 60136344, 60147669, 60159445 and 105 more |
| Date | Jun 16, 2021 |
| 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