(1)単回使用眼内レンズ挿入器、(2)多焦点後房レンズ（一般名）／(1)アクリジェットFLY(2)アクリバトリノバ Pro（販売名）。製造販売業者 わかもと製薬株式会社・法的整理番号 3-3015・クラス III（PMDA 医療機器回収）
- 掲載年月日
- 2025-09-17
- 一般名
- (1)単回使用眼内レンズ挿入器、(2)多焦点後房レンズ
- 販売名
- (1)アクリジェットFLY(2)アクリバトリノバ Pro
- 製造販売業者等名称
- わかもと製薬株式会社
- 法的整理番号
- 3-3015
- 備考
- 回収終了
- 区分
- 医療機器
- 管理番号
- pmda-3-3015
- 本文
- 回収概要
閉じる
令和 7年 9月17日作成
医療機器改修の概要
（クラスIII）
一般的名称及び販売名
一般的名称： (1)単回使用眼内レンズ挿入器、(2)多焦点後房レンズ
販売名 ： (1)アクリジェットFLY
(2)アクリバトリノバ Pro
対象ロット、数量及び出荷時期
（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
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100000101471214,100000101471222,100000101471224
数量
1833
出荷時期：2025年5月16日～2025年9月12日
製造販売業者等名称
製造販売業者の名称 ： わかもと製薬株式会社
製造販売業者の所在地： 東京都中央区日本橋本町二丁目2番2号
許可の種類 ： 第一種医療機器製造販売業
許可番号 ： 13B1X10426
改修理由
製品個装箱に貼付された特定用符号（バーコード、二次元コード）に表示不備が判明したため、自主改修を実施
いたします。
危惧される具体的な健康被害
本件はバーコードおよび二次元コード表示に関する不備であり、製品の品質、有効性及び安全性に影響はなく、
健康被害が発生する可能性はないと考えております。なお、現在までに本件に起因する健康被害の報告は確認さ
れておりません。
改修開始年月日
令和7年9月17日
効能・効果又は用途等
（1）眼内に挿入し、眼内レンズの挿入及び配置を導くために使用すること。
（2）無水晶体眼の遠方、中間、近方距離における視力補正（多焦点機構）及びこれに伴う眼鏡依存度の軽減
その他
納入先は全て把握しておりますので、各納入先に速やかに情報提供を行い、自主改修を実施いたします。
担当者及び連絡先
連絡先 ： わかもと製薬株式会社 医療用営業本部 医療機器推進部
電話番号： 0120-997-026または03-3279-0376
- answer_text
- (1)単回使用眼内レンズ挿入器、(2)多焦点後房レンズ（2025-09-17公表）の医療機器の回収のお知らせです。 回収概要 閉じる 令和 7年 9月17日作成 医療機器改修の概要 （クラスIII） 一般的名称及び販売名 一般的名称： (1)単回使用眼内レンズ挿入器、(2)多焦点後房レンズ 販売名 ： (1)アクリジェットFLY (2)アクリバトリノバ Pro 対象ロット、数量及び出荷時期 （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 7… 対象の製品をお持ちの場合は、メーカーまたは販売店の窓口にお問い合わせください。