International safety notice
We are currently manufacturing and selling the excimer laser system MEL80 (approval number 22000BZY00017000) (hereinafter "MEL8 PRK (laser refractive keratectomy) and PTK (therapeutic It has been confirmed that the company was importing and selling products with the ``superficial keratectomy'' (hereinafter referred to collectively as ``PRK and PTK'') installed. I did it. Since this function of MEL80 has not been approved in Japan, we will inform the medical institutions to which we deliver the function that we will stop using it. We have decided to collect the MEL80 and instruction manual.
Japan / PMDA Recalls · JPN · Jul 8, 2024
Key facts
| Title | We are currently manufacturing and selling the excimer laser system MEL80 (approval number 22000BZY00017000) (hereinafter "MEL8 PRK (laser refractive keratectomy) and PTK (therapeutic It has been confirmed that the company was importing and selling products with the ``superficial keratectomy'' (hereinafter referred to collectively as ``PRK and PTK'') installed. I did it. Since this function of MEL80 has not been approved in Japan, we will inform the medical institutions to which we deliver the function that we will stop using it. We have decided to collect the MEL80 and instruction manual. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | General name: Resol corneal surgical device for ophthalmology Sales name: Excimer laser system MEL80 |
| Manufacturer | Carl Zeiss Meditec Co., Ltd. |
| Models | 1006179, 1018811, MEL80 |
| Date | Jul 8, 2024 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
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