International safety notice
The odor of the parts (perfusion lure) used in the VERITAS Disposable Set II (VRT-AI) has been confirmed by an overseas manufacturer. We have received information that multiple complaints have been reported regarding cracks and damage. As a result, the possibility of cracks or breakage of perfusion lures in certain lots cannot be ruled out. We will collect it voluntarily.
Japan / PMDA Recalls · JPN · Sep 13, 2022
Key facts
| Title | The odor of the parts (perfusion lure) used in the VERITAS Disposable Set II (VRT-AI) has been confirmed by an overseas manufacturer. We have received information that multiple complaints have been reported regarding cracks and damage. As a result, the possibility of cracks or breakage of perfusion lures in certain lots cannot be ruled out. We will collect it voluntarily. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Cataract and vitrectomy device Sales name: VERITAS Vision System |
| Manufacturer | AMO Japan Co., Ltd. |
| Models | 60353449, 60330248, 60353450, 60316112, 60360065 |
| Date | Sep 13, 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