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<p>医药网3月16日讯 继去年向义齿开炮之后,今年的央视3.15晚会,医疗器械行业再度成为曝光对象之一。而此次被曝光的也是业内另一个整治“老大难”产品——角膜塑形镜(俗称“OK镜”)。</p><p> </p><p> 去年,央视曝光之后,全国各地掀起了针对义齿生产、经营<strong><span style="color: rgb(0, 153, 102);">企业</span></strong>的整治风暴,不少企业被立案、处罚,甚至吊销证照。今年,角膜塑形镜、乃至彩色平光隐形眼镜(美瞳),也会很快就掀起整治风暴吗?</p><p> </p><p><strong> 三无公司售卖医疗器械 </strong><strong>魔爪伸进几百所学校</strong></p><p> </p><p> 央视“3.15”晚会曝出郑州市科视视光技术有限公司角膜塑形镜背后不为人知的秘密。</p><p> </p><p> 教育部与卫生部制定的《中小学生<strong><span style="color: rgb(0, 153, 102);">健康</span></strong>体检管理办法》明确规定,体检机构必须是持有有效的《医疗机构执业许可证》、由政府举办的公立性医疗机构。</p><p> </p><p> 但由销售角膜塑形镜的科视视光和民营<strong><span style="color: rgb(0, 153, 102);">医院</span></strong>黄河科技学院附属医院组成的一支无资质、无医学背景、无认证的“三无体检队”进入郑州、开封、焦作等城市的几百所中小学进行体检,要求体检的孩子填写“视力异常登记表”获取其个人信息,截止到目前已获得134280条学生信息。</p><p> </p><p> 信息获取后,科视视光谎称为郑州市中小学近视防治中心骗取家长信任,在没有医疗机构执业许可证,没有眼科医生的情况下进行角膜塑形镜的验配。</p><p> </p><p> 科视视光所销售的角膜塑形镜,市场上俗称OK镜,是一种用来矫治屈光不正的第三类<strong><span style="color: rgb(0, 153, 102);">医疗器械</span></strong>,验配不合格或致角膜上皮脱落,严重引发角膜感染。</p><p> </p><p> 按规定,角膜塑形镜必须在具有《医疗机构执业许可证》的二级及以上医疗机构进行验配,验配医师应具有中级以上眼科执业医师资格,技师具有中级以上技师职称,并须在眼科医生的配合下完成验配工作。这些规定在科视公司工作人员的眼里形同虚设。</p><p> </p><p> 另外,国家药监局规定,我国已经批准上市角膜塑形镜的矫正屈光度最高为600度,并要求此类产品说明须标注8岁以下<strong><span style="color: rgb(0, 153, 102);">儿童</span></strong>禁用。但记者在科视公司看到了近视达到1300度以及年仅6岁9个月的验配者信息。</p><p> </p><p> 科视公司销售的是美国“欧几里得”角膜塑形镜,也只有一种型号,而在科视公司的各个销售门店,“欧几里得”角膜塑形镜却是分成四种型号进行销售的,价格从5800元到13800元不等。</p><p> </p><p><strong> 最新消息:执法人员已到郑州科视视光调查</strong></p><p> </p><p> 另据央视消息,3·15曝光后,执法部门人员已经立即来到郑州科视视光有限公司总部进行调查。</p><p> </p><p> 现场发现:验光室里一个写着更衣室的房间,存放着很多纸质的档案,员工称这些都是客户的资料。</p><p><br /></p><p><br /></p><p style="white-space: normal;"><span style="color: rgb(62, 62, 62); 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