Johnson & Johnson Medical Limited announces an extension of the voluntary recall of certain 1•DAY ACUVUE® TruEye® Brand Contact Lenses (Narafilcon A) in Ireland.
The voluntary recall is only for those products with the affected lot numbers listed on the package (see below for details on how to identify affected product). 1•DAY ACUVUE® TruEye® (narafilcon A) contact lenses without the affected lot numbers can continue to be used.
In August, the company announced a voluntary recall of select lots of 1•DAY ACUVUE® TruEye® (narafilcon A) following a limited number of complaints in which wearers described unusual stinging or pain upon insertion.
The decision to expand the voluntary recall follows the company’s extensive review of its manufacturing process which identified the potential for some lenses to have higher than expected levels of a processing aid used in 1•DAY ACUVUE® TruEye® (narafilcon A), and identified a small percentage of contact lenses in the expanded lots that do not meet internal manufacturing requirements.
Complaint monitoring indicates no increase in health-related complaints related to this product variation. While these reports, along with the findings from the company’s continued testing, indicate a lower likelihood of the occurrence of stinging than the earlier recalled lots, Johnson & Johnson Vision Care is taking this action as a precaution to provide wearers greater confidence that they will experience the comfort they expect from 1•DAY ACUVUE® TruEye® (narafilcon A).
Corrective and preventive actions have been identified for sources of variation and will be implemented prior to restarting production on those manufacturing lines that produced the affected product. In the interim, 1•DAY ACUVUE® TruEye® (narafilcon A) will continue to be supplied via other manufacturing lines.
For additional information and advice as well as the process for returning affected product and receiving replacement contact lenses, patients should contact their Eye Care Professional.
Consumers can check the lot number on the products outside packaging to see if it is from one of the affected lot numbers and if so discontinue use and contact their Eye Care Professional.
How to identify affected product
To identify affected product, wearers should first locate the bar code on the outer packaging and/or individual contact lens container(see examples below). All 1•DAY ACUVUE® TruEye® (narafilcon A) lots affected by this recall begin with 492 or 502, with the first 6 digits of the lot numbers falling between 492237 – 492498 and between 502080-502269. Consumers are advised to discontinue use of product meeting these descriptions and contact their Eye Care Professional for information on how to return product and obtain replacement product.
