International safety notice
We are currently manufacturing and selling a single-use ophthalmological knife nuclear segmentation system miLOOP (certification number 302AHBZX0001100) 0) (hereinafter referred to as ``miLOOP''), it was discovered that the legal label did not include ``single use''. Ta.
Japan / PMDA Recalls · JPN · Dec 16, 2024
Key facts
| Title | We are currently manufacturing and selling a single-use ophthalmological knife nuclear segmentation system miLOOP (certification number 302AHBZX0001100) 0) (hereinafter referred to as ``miLOOP''), it was discovered that the legal label did not include ``single use''. Ta. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Single-use ophthalmic knife Sales name: Nuclear segmentation system miLOOP |
| Manufacturer | Carl Zeiss Meditec Co., Ltd. |
| Models | FG22121410, FG23012010, FG22093010, FG22081810, FG22112410, FG22090110, FG22101010 |
| Date | Dec 16, 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