International safety notice
Previously, this product was manufactured and sold as a separate reusable item called "Laminar Reuse," but it is now available for single use. We have also obtained manufacturing and sales approval for "Phaco Pack", a product for use in It was decided to manufacture and sell it as a pack. Appropriately changed ``Phaco Pack'' was attached, but regarding the legal display label, the ``Laminar'' before the change was attached. It has been discovered that the product was shipped with a "Reuse" tag attached to it, so we have confirmed that the incorrectly labeled product from that lot was shipped. We will collect it voluntarily.
Japan / PMDA Recalls · JPN · Jul 27, 2021
Key facts
| Title | Previously, this product was manufactured and sold as a separate reusable item called "Laminar Reuse," but it is now available for single use. We have also obtained manufacturing and sales approval for "Phaco Pack", a product for use in It was decided to manufacture and sell it as a pack. Appropriately changed ``Phaco Pack'' was attached, but regarding the legal display label, the ``Laminar'' before the change was attached. It has been discovered that the product was shipped with a "Reuse" tag attached to it, so we have confirmed that the incorrectly labeled product from that lot was shipped. We will collect it voluntarily. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Cataract and vitrectomy device Sales name: Phaco Pack (OPOM20LD) |
| Manufacturer | AMO Japan Co., Ltd. |
| Models | 60209772 |
| Date | Jul 27, 2021 |
| 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