International safety notice
With these products, there have been increasing reports of cases of higher-than-normal increases in intraocular pressure after implantation of intraocular lenses. The inside of the nozzle of this product's injector is coated with a coating material (PVP: Coated with polyvinylpyrrolidone. As a result of the investigation, it was discovered that a particular PVP lot physically clogged the aqueous humor drainage route. We will voluntarily recall products using.
Japan / PMDA Recalls · JPN · Jul 11, 2023
Key facts
| Title | With these products, there have been increasing reports of cases of higher-than-normal increases in intraocular pressure after implantation of intraocular lenses. The inside of the nozzle of this product's injector is coated with a coating material (PVP: Coated with polyvinylpyrrolidone. As a result of the investigation, it was discovered that a particular PVP lot physically clogged the aqueous humor drainage route. We will voluntarily recall products using. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Posterior chamber lens with inserter Sales name: (1) Nex Road System SP (2) Nex Road System SP Clear |
| Manufacturer | Nidek Co., Ltd. |
| Models | UEX20062, UEX33581, UHX20804, R4X41642, UHX19110, R7X39108, UGX00820, R7X38886, R4X44335, R5X25639, R0X38509, UFX07830 and 18593 more |
| Date | Jul 11, 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