International safety notice
The overseas manufacturer has confirmed that the welding part of the housing part and cover part of the cassette part of this product does not comply with the manufacturing standards. We have received a report that a product with a difference exceeding the value has been confirmed, so we will voluntarily recall the lot.
Japan / PMDA Recalls · JPN · Dec 15, 2022
Key facts
| Title | The overseas manufacturer has confirmed that the welding part of the housing part and cover part of the cassette part of this product does not comply with the manufacturing standards. We have received a report that a product with a difference exceeding the value has been confirmed, so we will voluntarily recall the lot. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Cataract and vitrectomy device Sales name: (1) White Star Signature (2) Compact intuiv |
| Manufacturer | AMO Japan Co., Ltd. |
| Models | 60326033, OPO73, 60373238, OPO80 |
| Date | Dec 15, 2022 |
| 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