Generic Name: (1) Single-use Intraocular Lens Inserter, (2) Multifocal Posterior Chamber Lens — Brand Name: (1) Acrijet Fly — (2) Acrivatrinova Pro
- Recalling firm
- Name of Manufacturer and Distributor: Wakamoto Pharmaceutical Co., Ltd. — Address of Manufacturer and Distributor: 2-2-2 Nihonbashi-Honcho, Chuo-ku, Tokyo — Type of License: Class I Medical Device...
- Product
- Lot: （1）単回使用眼内レンズ挿入器 アクリジェットFLY 対象ロット番号 1000245258,1000245259 数量 793 （2）多焦点後房レンズ アクリバトリノバ Pro 対象シリアル番号 100000101350010,100000101350011,100000101350012,100000101350013,100000101350014 100000101350015,100000101350016,100000101350017,100000101350018,100000101350019 100000101350020,100000101350022,100000101350023,100000101350024,100000101350025 100000101350026,100000101350027,100000101350028,100000101350029,100000101350030 100000101350031,100000101350032,100000101350034,100000101350036,100000101350039 100000101350040,100000101350041,100000101350042,100000101350043,100000101350060...
- Reason
- We have discovered an error in the display of the identification code (barcode or QR code) affixed to the individual product packaging and will be conducting a voluntary recall.
- Classification
- Class III
- Category
- medical device recall
- Country
- Japan
- Agency
- PMDA-DEVICE
- Status
- Ongoing
Official recall notice from PMDA-DEVICE
Recall details on Nibble Recalls: https://trynibble.app/recalls/9c1d53aa-f21b-4058-8fca-eb0164d7fe94