Events

ProClear Toric Soft Hydrophilic Contact Lenses 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Cooper Vision Caribbean Corp. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    69160
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-0134-2015
  • 사례 시작날짜
    2014-09-17
  • 사례 출판 날짜
    2014-10-24
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-06-10
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129775
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Lenses, soft contact, daily wear - Product Code LPL
  • 원인
    Routine quality monitoring system has identified that a limited number of lots were manufactured with the cylinder axis outside the allowable specification.
  • 조치
    The firm sent out a notification letter with the following instructions: Please take the following actions immediately: " Examine your inventory for any affected lot numbers o Use the enclosed report to inspect your inventory for affected product that is still in your Warehouse. " Stop any further distribution of the specified lots of Preclear T oric lenses. " Quarantine any Preclear Toric lenses with the specified lot numbers. " Within the next five (5) business days, please complete the attached Recall Response Form and fax it to 866-484-1048 or scan and email to info@coopervision.com. o If you have indicated that you have product to return, you will be contacted by a CooperVision Representative with instructions for pick-up and removal of affected, quarantined product. Your account will be credited once the product is returned and processed. This action is being taken in full cooperation with the Food and Drug Administration (FDA). The recall only affects Proclear T oric lenses with the lot numbers specified on the enclosed list. No other Preclear T oric products- or any other CooperVision products - are affected.

Device

ProClear Toric Soft Hydrophilic Contact Lenses
  • 모델명 / 제조번호(시리얼번호)
    10029500013022 10029550001022 10036550020022 10055500013022 10099500007022 10106500024022 10125500021022 10169500001022 10195550000022 10423500014022 10423550004022 10424500021022 10426500012022 10427500014022 10427500015022 10427500016022 10427500017022 10427500018022 10428500020022 10428500021022 10428500022022 10428500023022 10428500024022 10428500025022 10429500006022 10429550000022 10430500016022 10430500017022 10430500018022 10430500019022 10430500020022 10019550013017 10089500019017 10089500020017 10159500008017 10229550003017 10001500011008 10001500012008 10003550007008 10003550008008 10007500018008 10007500019008 10007550010008 10008500014008 10008500015008 10010550020008 10011500013008 10011550013008 10016550012008 10024500018008 10024550004008 10037500023008 10037550008008 10043500019008 10043500020008 10044550009008 10044550010008 10045500015008 10045500016008 10046500024008 10046550006008 10052500021008 10052550006008 10052550007008 10053550012008 10053550013008 10073500023008 10073500024008 10073500025008 10077500031008 10077500032008 10077500033008 10078500032008 10078500033008 10080550002008 10086500022008 10086500023008 10094500017008 10094500018008 10107500027008 10107500028008 10107550003008 10113500023008 10113500024008 10114500029008 10115500026008 10115500027008 10115550002008 10116500029008 10116500030008 10116550002008 10122500020008 10123500030008 10148550001008 10156500016008 10156550004008 10183550000008 10183550001008 10184500006008 10185500007008 10192500005008 10193500014008 10211550004008 10213500017008 10217500016008 10218500014008 10226500023008 10234500010008 10234500011008 10247500020008 10247500021008 10253500009008 10254500014008 10255500020008 10255500021008 10256500010008 10262500014008 10263550000008 10009550018007 10014500016007 10014500017007 10020500020007 10020500021007 10054550013007 10084500019007 10084500020007 10090500023007 10124500028007 10154550000007 10160500009007 10194500017007 10194550003007 10224500011007 10224550001007 10230550003007 10002500013006 10002550013006 10002550014006 10007500019006 10007550012006 10008500011006 10008550020006 10010550015006 10014500017006 10014550010006 10015500022006 10015550005006 10017550013006 10017550014006 10026550009006 10030500021006 10030550002006 10030550003006 10033500015006 10033550003006 10033550004006 10035500016006 10035500017006 10035550015006 10036500010006 10036550018006 10043500015006 10043500016006 10043550006006 10045500021006 10045550011006 10053500015006 10053550012006 10053550013006 10063500029006 10072500018006 10072500019006 10072500020006 10077500021006 10078500027006 10078550005006 10084500021006 10084500022006 10084500023006 10084500024006 10084500025006 10085500022006 10085500023006 10085500024006 10087500021006 10096500025006 10096550002006 10100500015006 10100500016006 10103500012006 10103500013006 10103500014006 10105500026006 10106500026006 10106500027006 10106550002006 10113500019006 10113500020006 10115500030006 10115500031006 10123500026006 10123500027006 10133500017006 10133500018006 10133500019006 10142500019006 10147500019006 10147550002006 10148500021006 10150550005006 10154500014006 10154550001006 10157500021006 10170500005006 10173500006006 10175500013006 10175500014006 10176500016006 10176500017006 10183500004006 10185500011006 10212500025006 10217500013006 10217500014006 10217500015006 10218500018006 10218500019006 10220500022006 10236500018006 10240500010006 10243500010006 10245500023006 10245500024006 10245500025006 10246500023006 10246500024006 10253500007006 10255500019006 10263500018006 10273500013006 10273500014006 10427500018006 10427550012006 10427550013006 10429500018006 10430550002006
  • 의료기기 분류등급
    Ophthalmic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: US (nationwide) and internationally to: Canada, Latin America, EU, Asia Pacific, and Africa/Central Eurasia countries.
  • 제품 설명
    ProClear Toric contact lenses are made from a material containing 62% water and 38% omafilcon B, a random copolymer of 2-hydroxyethylmethacrylate and methacrylic acid. The lenses have a tint (VAT Blue 6) which is added to make the lens more visible for handling.
  • Manufacturer
    Cooper Vision Caribbean Corp.

Manufacturer

Cooper Vision Caribbean Corp.
  • 제조사 주소
    Cooper Vision Caribbean Corp., #500 Road 584, Amuelas Industrial Park, Juana Diaz PR 00795
  • 제조사 모회사 (2017)
    The Cooper Companies, Inc.
  • Source
    USFDA