soft 72 soft hydrophilic contact lenses 의 안전성 경고

Safety alert

2017-03-14

2017-03-14

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20170314.html

Medical device safety alert: menicon soft 72 soft hydrophilic contact lenses the medicines and healthcare products regulatory agency (mhra), united kingdom has posted a medical device safety alert concerning menicon soft 72 soft hydrophilic contact lenses, manufactured by menicon ltd. [affected lot numbers: 16375331, 16375454, 16376215 ,16376216, 16376225, 16376227, 16376256, 16376257, 16376383, 16376385, 16376904, 16376906, 16376939, 16376940, 16376979, 16377169, 16377309, 16377510, 16377519, 16377621, 16377622, 16377623, 16377624, 16377625, 16377836, 16377838, 16377945, 16377946, 16378434, 16378435, 16379224, 16375729, 16376419, 16376463, 16376907, 16377409, 16375462, 16376419, 16376463, 16376907 and 16377409]. according to the manufacturer, a serious problem was found in the manufacturing process of menicon soft 72 contact lenses as manufactured on 21 november 2016. instead of using the regular saline solution, the manufacturer has grounds to suspect that for some menicon soft 72 contact lenses, peroxide solution was wrongly used as shipping solution in the contact lens packaging process. if patients insert such a lens directly from the shipping container onto the eye, immediately an eye irritation, eye pain and a red eye effect may occur. product recall is on-going. at time, the known risk for menicon soft 72 contact lenses containing the wrong shipping solution for that manufacturing date is calculated as less than 10 percent. the manufacturer advises customers not to use and not to insert onto the eye any menicon soft 72 contact lens from the affected lot numbers, if such lenses are still in the original and unopened packaging. if patients already have used the affected products, but no such symptom occurred when the lens was initially put onto the eye, then the lens can be safely worn. however, concerned lens should be replaced with new one. if patients feel a sense of discomfort, he/she should remove the lenses and contact his/her eye care professional. for details, please refer to the mhra website: https://www.Gov.Uk/drug-device-alerts/field-safety-notices-6-march-10-march-2017 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 14 march 2017.