International safety notice
A foreign manufacturer has requested that the welded part of the housing part and cover part of the cassette part of the product be approved by manufacturing standards. We have received a report that a product with a level difference that exceeds the capacity value has been confirmed. We will voluntarily recall the items.
Japan / PMDA Recalls · JPN · Jun 1, 2023
Key facts
| Title | A foreign manufacturer has requested that the welded part of the housing part and cover part of the cassette part of the product be approved by manufacturing standards. We have received a report that a product with a level difference that exceeds the capacity value has been confirmed. We will voluntarily recall the items. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Cataract and vitrectomy device Sales name: VERITAS Vision System |
| Manufacturer | AMO Japan Co., Ltd. |
| Models | 60400795, 60425389, 60299303, 60306933, 0314677, 60309847, 60314642, 60378842, 60309848, 60304175, 60305661, 60294291 and 13 more |
| Date | Jun 1, 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