International safety notice
The foreign manufacturer of the product, Dutch Ophthalmic Research Center International b.v. A product was shipped that did not allow manual operation (extending and retracting) of the bar tip (tip), so we have issued a recall notice. I have been contacted. The shape of the slider hole does not match, and the slider cracks when screwed in, making it impossible to secure the slider properly. I found out that it was caused by not having it. However, we have decided to voluntarily recall the product.
Japan / PMDA Recalls · JPN · Jan 22, 2024
Key facts
| Title | The foreign manufacturer of the product, Dutch Ophthalmic Research Center International b.v. A product was shipped that did not allow manual operation (extending and retracting) of the bar tip (tip), so we have issued a recall notice. I have been contacted. The shape of the slider hole does not match, and the slider cracks when screwed in, making it impossible to secure the slider properly. I found out that it was caused by not having it. However, we have decided to voluntarily recall the product. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common Name: Ophthalmic Laser Photocoagulator Sterilized Probe Brand name: DORC disposable intraocular laser probe |
| Manufacturer | RL Medical Co., Ltd. |
| Models | 9146-X-X-1, AU-7223ALC-6 |
| Date | Jan 22, 2024 |
| 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