International safety notice
In a specific manufacturing lot of this product, when inserting an intraocular lens, there was a risk of "foreign matter on the lens surface" due to damage to the nozzle of the inserter. Due to an increase in reports of "damage to lens optics" and "damage to lens optics", we are voluntarily recalling products with the affected serial numbers. vinegar.
Japan / PMDA Recalls · JPN · Apr 5, 2023
Key facts
| Title | In a specific manufacturing lot of this product, when inserting an intraocular lens, there was a risk of "foreign matter on the lens surface" due to damage to the nozzle of the inserter. Due to an increase in reports of "damage to lens optics" and "damage to lens optics", we are voluntarily recalling products with the affected serial numbers. vinegar. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Posterior chamber lens with inserter Sales name: HOYA Vivinex Toric |
| Manufacturer | HOYA Co., Ltd. |
| Models | 2HM60663, 2FM70426, 2FM60A02, 2HM705G1, 2HM60207, 2KM700S7, 2HMZ00N6, 2FM602U4, 2JMY01H9, 2GM60061, 2GM600N1, 2GM70235 and 14474 more |
| Date | Apr 5, 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