International safety notice
We are currently manufacturing and selling "Treatment Pack" (laser lens for eye surgery, certification number: 227A) It has been discovered that there are some discrepancies between the contents of the manufacturing and sales certificate for HBZX00031000) and the products being sold. I did. Therefore, we have decided to voluntarily recall the product.
Japan / PMDA Recalls · JPN · May 30, 2024
Key facts
| Title | We are currently manufacturing and selling "Treatment Pack" (laser lens for eye surgery, certification number: 227A) It has been discovered that there are some discrepancies between the contents of the manufacturing and sales certificate for HBZX00031000) and the products being sold. I did. Therefore, we have decided to voluntarily recall the product. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Laser lens for ophthalmic surgery Sales name: Treatment pack |
| Manufacturer | Carl Zeiss Meditec Co., Ltd. |
| Models | JS23000021, JS2231063, JS2241011, JS23000006, JM22000008, JM22000010, JS2113026, JS2240031, JS23000033, JS2114027, JS2115015, JS2231064 and 33 more |
| Date | May 30, 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