Events

Device Recall AVAIRA 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 CooperVision Inc. 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
    60008
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-0044-2012
  • 사례 시작날짜
    2011-08-19
  • 사례 출판 날짜
    2011-10-14
  • 사례 상황
    Completed
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104226
  • 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
    This recall was initiated because of the unintended presence of a residue (silicone oil) on lenses from certain lots of avaira toric contact lenses. the company received complaints of temporary hazy or blurry vision and discomfort, most likely caused by transient or reversible swelling of the surface layer of the cornea, which is known as corneal epithelial edema. corneal epithelial edema results.
  • 조치
    The firm, CooperVision sent an "Urgent: Company Initiated Voluntary Medical Device Recall - Contact Lenses" notification letter to all affected consignees. The notice identified the product, the problem, and the actions to be taken. The letter includes an attached "Recall Response Form" that consignees are required to complete and fax to (585) 889-5688. Consignees were instructed to immediately examine their inventory, stop any further distribution, quarantine and return product subject to recall. In addition, consignees were told if they have further distributed the affected product to notify customers at once of this product recall. The letter states that accounts will either be credited or exchanged for an unaffected product. If you have any further questions, call 1-800-341-2020.

Device

Device Recall AVAIRA
  • 모델명 / 제조번호(시리얼번호)
    Affected Packaging Lot Numbers: 10437500002006 10440550000010 10444500007006 10445500007010 10445550003002 10437500004002 10440550000016 10444500008002 10445500007014 10445550003004 10437500005016 10440550001004 10444500008006 10445500007016 10445550003005 10437500006010 10441500003002 10444500009004 10445500007018 10445550003007 10437500006016 10441500004002 10444500009006 10445500007020 10445550003009 10437500006018 10441500004008 10444500010004 10445500007022 10445550003010 10437500007004 10441550000006 10444500010006 10445500007024 10445550003014 10437500007012 10441550001008 10444500011004 10445500008000 10445550003016 10437500007014 10442500002016 10444500011006 10445500008002 10445550004004 10437500007016 10442500003008 10444550001003 10445500008004 10445550004005 10437500007020 10442500004002 10444550001006 10445500008006 10445550004010 10437500008014 10442500004014 10444550001007 10445500008008 10445550004014 10437550000004 10442500005008 10444550001010 10445500008010 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10549500012002 10560500011014 10562500014010 10562550000009 10549500013014 10560500013014 10562500014014 10562550006006 10549550003008 10560500013024 10562500014016 10562550006016 10550500011016 10560500014002 10562500014018 10562550008010 10550500011024 10560500014020 10562500014020 10562550008014 10551500012006 10560500015016 10562500014024 10562550008016 10551500012016 10560500016020 10562500015000 10562550009006 10551500012020 10560550004016 10562500015004 10562550009024 10551500013014 10561500004015 10562500015010 10551550000003 10561500005018 10562500015014 10552500010002 10561500007018 10562500015016 10552500011008 10561500009008 10562500015020 10552500013002 10561500009016 10562500015022 10552500013006 10561500009018 10562500015024 10552500015006 10561500010008 10562500016000 10552550002010 10561500011008 10562500016006 10552550003010 10561500011014 10562500016008. --- 10/12/11 EXPANSION - Addtional Affected Packaging Lot Numbers: 10439550000002, 10462500003002, 10488500004002,  10445500012000, 10443500003004, 10462500005002, 10482500003003, 10452500004016, 10443500006006, 10464500004002, 10490550002004,  10452500007014, 10448500003006, 10464500005002, 10452500008006, 10452500006010, 10466500003003, 10490500007004, 10454500004023, 10456500005004, 10476500005008, 10454500005001, 10453500012010, 10472500007004, 10481550002008, 10454500006000, 10447550000014, 10461500005006, 10454500008019, 10454500012018, 10462550000006, 10454500011014, 10447550000020, 10464500008006, 10489500001010, 10454500013018, 10454500014022, 10471500001006, 10454500017010,  10462500006000, 10471500009010, 10454550004009, 10463500005000, 10455500009012, 10490500007010, 10454550006016, 10463500007000, 10463500007014, 10454550007007, 10464550002000, 10462500004020, 10490500010016, 10454550008008, 10472500010020, 10482500003002, 10482500006020, 10490550003023, 10472500007000, 10490500013022, 10535500017016.
  • 의료기기 분류등급
    Ophthalmic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) including Puerto Rico and the countries of: Australia, Canada, Europe, Germany, Hong Kong, Italy, New Zealand, and Spain.
  • 제품 설명
    AVAIRA Toric (enfilcon A) TORIC soft (Hydrophilic) Contact Lenses, 6 SOFT CONTACT LENSES FOR ASTIGMATISM, CooperVision, Scottsville, NY 14546 USA; Juana Diaz, PR 00795 USA; Hamble SO31, 4RF, UK; Device Listing # D033736. || Product Usage: Indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00- to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters. The AVAIRA Soft Contact Lens is indicated for single - use disposable wear and daily wear. When prescribed for frequent replacement, the lens may be disinfected using a chemical or hydrogen peroxide disinfecting system.
  • Manufacturer
    CooperVision Inc.

Manufacturer

CooperVision Inc.
  • 제조사 주소
    CooperVision Inc., 180 Thruway Park Dr, W Henrietta NY 14586-9798
  • 제조사 모회사 (2017)
    The Cooper Companies, Inc.
  • Source
    USFDA