ACUVUE®OASYS® with HYDRACLEAR® Plus Contact Lenses 의 안전성 경고

Safety alert

2012-01-10

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/press_20120111.html

Recall of selected lots of contact lenses the department of health (dh) today (january 10) drew public attention to the recall of three lots of contact lenses - acuvue®oasys® with hydraclear® plus contact lenses - because the affected products were found to have higher than expected levels of a diluting agent which could affect lens performance due to reduced wettability. a dh spokesman revealed that the department, through its routine surveillance on medical devices, found that the united kingdom's medicines and healthcare products regulatory agency had posted a recall notice issued by the manufacturer, johnson & johnson vision care. according to the manufacturer, the problem was due to an isolated interruption in the lens rinsing process on one manufacturing line and the cause has already been rectified. the manufacturer reported no consumer complaints or adverse events so far, and advised that while wearers of the affected lenses may experience some eye discomfort or eye redness upon lens insertion, long-term health consequences are highly unlikely. "the dh has immediately contacted the product's local supplier and found that the affected lots have not been distributed in hong kong. although the three lots under recall are not distributed in hong kong and we have no record of related adverse events here, the fact that there may be occasional users in the territory who have somehow obtained the affected products from abroad justify a public alert," the spokesman added. details of the affected products (8.8 base curve) are listed below. consumers are advised to check the printed lot number reading from left to right on the outer package and on each individual contact lens container to identify the affected products. lot number power l001rj5 -2.00d l001rj8 -2.75d l001rj9 -3.00d "those customers who have used the said products and are either feeling unwell or in doubt should consult their healthcare professionals for advice as soon as possible." the dh has informed public and private hospitals, relevant medical associations and optometrist associations about the issue. ends.