一覧へ戻る

平成17年6月23日作成
平成17年6月28日改訂(*)

医療機器回収の概要

(回収クラスIII)



  1. 一般名及び販売名

    
    一般名:眼鏡レンズ
    
    販売名(*):セイコースーパーP−1 1.74
    
          セイコーP−1シナジー1.74AS
    
          A-1クレスタ 1.74AS バリアクリーン
    
          ワシン WP174HG (S) C&P-S UV
    
          UVG エクリオSY174 クリーンストロングコート
    
          UVガード エクリオSY174 ストロングコート HP
    
          UVガード エクリオSY174 HP
    
          ワシン WS174HG (S)
    
          グロリアS 1.74 AS
    
          エニビュー1.74AS
    
          グランデ1.74AS
    
          ラヴィ 1.74
    
          キクチスーパーエポックス 1.74
    
          セイコープレステージA-Z
    
          セイコープレステージ
    
          アベスタAZ UV1.74
    
          グロリアZ1.74
    
          UVGスプレンド174AZクリーンストロングコートHP
    
          ワシン WS174BA (S) C&P-S UV
    
          アベスタ UV1.74
    
          UVガード スプレンド174AS HP
    
          UVGスプレンド174ASクリーンストロングコートHP
    
          プリオールUV 1.74バリアクリーン
    
          ワシン WS174AS
    
          ワシン WS174AS (S) C&P-S UV
    
          プレナリー
    
          ラブ 174PIR
    
    
    
    
  2. 対象ロット、数量及び出荷時期

    
    対象ロット:790ロット(*)
    
    対象製造番号(*):
    
    387979706001,387945506001,387942006001,349636606001,349873906001,387683406001
    
    387877006001,388014806001,388351406001,335856106001,387609406001,387952606001
    
    388049706001,388030606001,316505306001,302515006001,303127006001,303041006001
    
    301979206001,303217806001,301659106001,302044806001,402274506001,402251206001
    
    401642706001,401952706001,402055306001,402419206001,302011006001,303042706001
    
    303042606001,302421506001,302336106001,301693606001,302544206001,302387106001
    
    342169706001,301668606001,302349506001,302614206001,302107406001,302627606001
    
    388112606001,402072606001,301190306001,349928706001,401697206001,302374206001
    
    349633606001,402202806001,302345106001,387900206001,401648906001,302981706001
    
    388256106001,401602006001,301989106001,349641706001,402501306001,302035506001
    
    387752706001,402087706001,321391506001,387975106001,401766806001,321391406001
    
    387659006001,402233806001,402185406001,388033706001,401289006001,101140106001
    
    387724506001,402387706001,317639406001,387810306001,402304306001,101439006001
    
    387848106001,402803906001,301569206001,387928406001,401606006001,640181806001
    
    387887406001,402585906001,502384406001,388035806001,402023406001,401773306001
    
    387833206001,402321006001,402191206001,387717706001,401683506001,587979806001
    
    387737706001,321382906001,602493406001,387891606001,321382806001,301784306001
    
    388410306001,317146406001,640301306001,388203106001,317143806001,301534106001
    
    388099206001,317152806001,529080706001,387731906001,529059206001,317129906001
    
    349928606001,317131006001,368601806001,387860506001,321387706001,368586606001
    
    387756506001,317137606001,435119206001,388139106001,529056906001,303116506001
    
    388036006001,529058606001,302317206001,387946906001,529051606001,302033406001
    
    387928206001,529069706001,301738506001,349913706001,317153506001,460755306001
    
    349913606001,317153306001,502177306001,387459206001,321388406001,501759006001
    
    388187506001,321388306001,501759506001,349981106001,529078006001,501758606001
    
    349678606001,529077806001,301476306001,387865706001,317146106001,321393706001
    
    487915806001,529059106001,601742306001,349948306001,529064106001,315751906001
    
    388049306001,317137406001,315755606001,349678906001,317121206001,101601106001
    
    388150906001,529083306001,102311006001,387899506001,529081306001,529093306001
    
    388183206001,529074206001,529077206001,387825106001,529085106001,429067106001
    
    387748106001,317155406001,302172206001,387608606001,317143906001,339694506001
    
    187857706001,317133806001,301927906001,388363106001,317134806001,402241606001
    
    335853306001,317143206001,402974306001,388410706001,317155806001,402246606001
    
    331413906001,317134406001,302981006001,388132106001,321381506001,302099606001
    
    387877206001,317148206001,640192206001,387686906001,317134106001,335687606001
    
    387996706001,317120906001,347769306001,387768506001,317154206001,302204206001
    
    349948206001,317154006001,317641406001,387946706001,317131206001,302469406001
    
    388075706001,317136706001,602193006001,335854206001,317130306001,429082306001
    
    387931006001,317156606001,429081206001,387551506001,317153806001,102078206001
    
    387953606001,317153706001,317149106001,349927606001,317147206001,403126006001
    
    388159206001,321385606001,301735606001,387948806001,317142206001,302327606001
    
    387866806001,317131406001,601655506001,387823606001,317118506001,560726406001
    
    387905206001,317136506001,102815806001,388034706001,321385906001,102446206001
    
    349982206001,317152006001,101811906001,349648106001,321388606001,502441906001
    
    387836006001,317121006001,547400606001,387780606001,401796506001,329070806001
    
    487684606001,503196806001,349206706001,687678206001,503269406001,331389306001
    
    549935706001,502138106001,302201806001,587891406001,303285106001,302209406001
    
    549652906001,102906906001,302522406001,587920406001,402869506001,402328506001
    
    487925106001,402164706001,501695006001,588005906001,302410806001,502168206001
    
    588041006001,102034106001,501885706001,687602006001,502384006001,301757806001
    
    587900706001,502182106001,301950606001,587986206001,501481206001,337428806001
    
    549879006001,502701006001,602594206001,488034606001,501901606001,602394206001
    
    687887506001,502055806001,321394306001,488166206001,501895206001,301815906001
    
    587717106001,534974106001,401825906001,549948106001,501853906001,331650306001
    
    588040506001,302162406001,302403306001,588072706001,302618506001,317141106001
    
    587770006001,302792506001,349199906001,549692506001,301831606001,347700406001
    
    649980906001,402470306001,432164006001,487678006001,402814906001,402758106001
    
    587679806001,502097306001,402505206001,587395706001,502598806001,302169606001
    
    549645706001,502374606001,501942806001,487495806001,501860906001,301174706001
    
    526475306001,502354006001,302097106001,587691906001,502548906001,601682106001
    
    549634606001,502348906001,301998006001,549681606001,503040206001,301711306001
    
    587871506001,301595806001,301710606001,549644406001,303253006001,302670206001
    
    587860606001,302478806001,529064306001,549632306001,501828906001,102584406001
    
    549642606001,502607806001,101818006001,587729806001,501355806001,102006106001
    
    487947006001,301880306001,101593506001,549980306001,401027906001,501696106001
    
    587881106001,501830006001,512639406001,549932206001,501044406001,349167606001
    
    549632906001,501430706001,302083106001,588145506001,403018206001,602307906001
    
    549632406001,603279506001,640171506001,688315406001,402495406001,301879206001
    
    487894306001,402350706001,303074206001,488026706001,401529606001,615752106001
    
    587910106001,403146906001,302545306001,549927806001,502800506001,302414006001
    
    687662806001,501799006001,302282206001,588166806001,502137606001,401977206001
    
    687973806001,602155506001,402280006001,587658406001,403131306001,602327506001
    
    587709706001,601919406001,602212106001,588021506001,503147206001,526457206001
    
    535851406001,502513906001,526459606001,587933606001,501057506001,526456006001
    
    587949006001,502871206001,626458006001,587721006001,500432406001,401713406001
    
    588001406001,502136006001,649315006001,587929306001,502894306001,633876206001
    
    549644806001,502385606001,601081706001,587836306001,501982906001,402592806001
    
    587865906001,302198806001,402318006001,588288706001,502553206001,401596406001
    
    588344306001,602889706001,401806506001,687725106001,602728706001,502249906001
    
    549949806001,602406306001,301886806001,588015406001,602489206001,301886906001
    
    587675506001,388378006001,402419006001,587917606001,601731706001,317157106001
    
    587998606001,602600806001,317157006001,549935106001,601737506001,345419606001
    
    587873706001,602260406001,302005506001,549982306001,101917906001,601960006001
    
    549907006001,101337906001,501797606001,549907306001,102224206001,502115206001
    
    549605306001,102487006001,502063006001,549870506001,102174706001,602894606001
    
    587538106001,101649906001,602366906001,588096406001,101780106001,601058706001
    
    549698706001,102274706001,512649806001,587624406001,501693206001,512649606001
    
    588244206001,502201506001,602175406001,587692906001,502212306001,100838506001
    
    687947706001,502008406001,101590506001,587994406001,502201306001,302203006001
    
    488071506001,502212406001,302686806001,487867706001,320897706001,301955006001
    
    588027306001,320891206001,342198506001,588089806001,320898306001,301955606001
    
    549654406001,302438506001,503218006001,587645606001,339232806001,502003606001
    
    587693106001,320885206001,502287706001,587946406001,302420806001,502287206001
    
    587900106001,302474906001,502036506001,487957106001,301650806001,601917606001
    
    549651806001,301650706001,502481806001,688156106001,301721206001,543472606001
    
    588109006001,301621206001,660795306001,549641006001,301722706001,603035406001
    
    649651906001,301621106001,601814106001,535853106001,301673006001,549763606001
    
    549980406001,300640906001,360818206001,587588006001,301620806001,302162206001
    
    549681106001,301946406001,401673206001,687919506001,601653806001,402248506001
    
    687909606001,601982806001,501896006001,587843606001,601949706001,321392506001
    
    388006606001,601747306001,303254906001,588367506001,601716806001,302289406001
    
    322897406001,601597606001,302119006001,322898706001,601091306001,302197306001
    
    322893406001,601141206001,302045706001,316434206001,602699706001,302892406001
    
    316498506001,602791506001,317140406001,316438106001,601671406001,435296906001
    
    316427406001,602273206001,502096306001,316483006001,602526406001,602524106001
    
    316458806001,601321506001,102430506001,316534206001,302443906001,301705206001
    
    316492706001,360776806001,600745006001,316498406001,302206906001,302432106001
    
    316534306001,302638906001,301627806001,316497406001,301845206001,301630206001
    
    316458506001,302521606001,601287106001,316410106001,301600306001,301619806001
    
    316486306001,388366906001,302816006001,316459506001,301640106001,301699906001
    
    316444506001,302134906001,301704206001,316482106001,302281106001,301746806001
    
    316502206001,360416806001,360821006001,316433706001,301870806001,360868606001
    
    316482006001,302685006001,502558606001,316489806001,302411906001,512649706001
    
    316491806001,301853606001,301614506001,316487906001,301849706001,102080906001
    
    316482806001,502894006001,102278706001,316434006001,503101606001,401791106001
    
    316449306001,502558106001,302269706001,316491606001,502375006001,500811706001
    
    316532306001,502366306001,302620806001,316519006001,502475106001,401762506001
    
    316534806001,502005006001,102162906001,316497306001,502283106001,502473006001
    
    316488806001,501877206001,602553606001,316448306001,502722706001,311148706001
    
    316525806001,502401806001,101239606001,316486606001,502601406001,601973206001
    
    316404806001,503136606001,502716106001,316486206001,302299006001,302585006001
    
    316447406001,302615606001,388440606001,316368806001,301605906001,512652606001
    
    316435406001,301604706001,394430106001,316437406001,501817706001,394430206001
    
    316432106001,301597306001,316452206001,301994506001,316442106001,301660006001
    
    316447106001,301775806001,316443806001,301999106001,316460306001,302663106001
    
    316492406001,302186406001,316441906001,302430906001,316557106001,501864806001
    
    316482606001,501496806001,316494806001,502178906001,316434106001,501033006001
    
    316524406001,302064506001,316368606001,300970506001,316367906001,301670106001
    
    316478206001,301824606001,316485706001,302340606001,316508606001,302249706001
    
    316471806001,302583206001,316470906001,302351406001,301830806001,302552206001
    
    316518606001,302340406001,316508406001,310407006001,316516306001,310405706001
    
    349884706001,388361606001,588373706001,588451006001
    
    
    
    出荷数量 :1,560枚(*)
    
    出荷時期 :平成17年6月8日〜平成17年6月15日
    
    
    
    
  3. 製造販売業者等名称

    
    製造販売業者      :セイコーオプティカルプロダクツ株式会社
    
    製造販売業者の所    :東京都中央区日本橋堀留町1−2−10
    
    製造販売業者の許可の種類:第3種医療機器製造販売業
    
    製造販売業許可番号   :13B3X00084
    
    製造業者        :セイコーエプソン株式会社光学事業部
    
    製造業者の所在地    :長野県上伊那郡箕輪町中箕輪8793 
    
    製造業許可番号     :20BZ000074
    
    
    
    
  4. 回収理由

    
    当該自主回収製品において、表面コート膜の耐久性品質が通常レベルより低いことが、
    
    製造所の耐久試験の結果で判明しました。
    
    ユーザー使用において表面コート膜の剥がれを起こす恐れが推測されるため、
    
    自主回収します。
    
    
    
    
  5. 危惧される具体的な健康被害

    
    表面コート膜は、主にキズつきにくさを目的に施すものであり、万が一、表面コート膜が
    
    剥がれた場合においても、回収対象製品の使用による健康被害の発生の恐れは
    
    ありません。なお、現在まで回収対象製品において表面コート膜が剥がれた報告及び回収
    
    対象製品の使用による健康被害の報告はありません。
    
    
    
    
  6. 回収開始年月日

    
    平成17年6月20日
    
    
    
    
  7. 効能・効果又は用途等

    
    眼鏡レンズ
    
    
    
    
  8. その他

    
    納品先は全て特定されており、納品先には文書をもって通知し、自主回収し、
    
    通常品と交換します。
    
    
    
    
  9. 担当者名及び連絡先

    
    セイコーオプティカルプロダクツ株式会社  黒坂 芳功
    
    東京都中央区日本橋堀留町1−2−10
    
    電話番号:03-5645-5886
    
    FAX 番号:03-5645-5167