International safety notice
Regarding the product manufactured and sold by our company, in a foreign country, the outer cylinder fell off the handle during surgery, resulting in health concerns. One case of damage (retinal damage) occurred. As a result of our investigation, we found that during the manufacturing process, when removing and trimming unnecessary parts near the border between the handle and the outer cylinder, cutting Scratches caused by the tool coming into contact with the outer cylinder could not be eliminated due to a flaw in the inspection process, and the mechanical strength against external forces was poor. has been found to be contaminated with a vulnerable product that is missing. We have decided to voluntarily recall the products.
Japan / PMDA Recalls · JPN · Nov 29, 2024
Key facts
| Title | Regarding the product manufactured and sold by our company, in a foreign country, the outer cylinder fell off the handle during surgery, resulting in health concerns. One case of damage (retinal damage) occurred. As a result of our investigation, we found that during the manufacturing process, when removing and trimming unnecessary parts near the border between the handle and the outer cylinder, cutting Scratches caused by the tool coming into contact with the outer cylinder could not be eliminated due to a flaw in the inspection process, and the mechanical strength against external forces was poor. has been found to be contaminated with a vulnerable product that is missing. We have decided to voluntarily recall the products. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Cataract and vitrectomy device Sales name: Dispo Bipolar |
| Manufacturer | Nidek Co., Ltd. |
| Models | 231120, 240123, 240513, 18241-0979, 230720, 230817, 230323 |
| Date | Nov 29, 2024 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
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