27 September 2019
The Medicines and Healthcare products Regulatory Agency (MHRA) has confirmed that Johnson & Johnson Vision has voluntarily removed specific lots of its 1-day Acuvue Moist for Astigmatism contact lenses due to quality concerns.
In a statement online, the MHRA states that the recall “affects a low level of stock of certain lots of 1-day Acuvue Moist for Astigmatism lenses. If not already contacted, customers should return these lenses to their supplier. The affected lots may have particles on the contact lens or in the contact lens blister solution. If the particles are not noticed before insertion into the eye, this could cause eye redness or discomfort or corneal abrasion (damage to the surface of the eye). There have been no reports of serious adverse events to date.”
The MHRA confirmed that Johnson & Johnson Vision has “notified affected opticians and optometrists, recalling the affected lots, and has instructed them to contact patients who may have received the affected product.”
The agency advises that contact lens users who are concerned should speak to their optician or optometrist.
In its statement, the MHRA states that users of the contact lenses can check if their products are affected by looking at the lot number of the lens boxes against the list published by Johnson & Johnson Vision in the company’s field safety notice (FSN). Lot numbers are displayed on the back or side of each carton of 28 lenses, as well as on the foil cover of individual lenses.
MHRA group manager of device safety and surveillance, Mark Birse, commented: “While the risk is low, the MHRA takes the safety of the medicines and devices we regulate very seriously. It is therefore important that as many customers as possible are made aware of the need to check their lenses for these lot numbers. Contact lens users who still have concerns should contact their optician or optometrist. They can also report any adverse effects to the MHRA’s Yellow Card Scheme.”
A spokesperson at Johnson & Johnson Vision told OT: “Our top priority is patient safety and we hold ourselves to high standards for product quality and customer satisfaction. We are voluntarily recalling two full and one partial master lots of 1-day Acuvue Moist for Astigmatism contact lenses in Europe, the Middle East and Asia because they do not meet quality standards. The quantity of stock affected is low. We have identified the cause, taken corrective action, and are planning to implement even stronger manufacturing and quality controls based on learnings from this event. Acuvue brand contact lenses not impacted by this recall are safe when used as directed and can continue to be used with confidence.”
The spokesperson added that all customers in the UK with affected batches have now been contacted and the process of communicating with patients and returning the affected batches is underway. They stressed that a very small number of lenses were affected and there have been no reports of harm in the UK.
In a statement online, the MHRA states that the recall “affects a low level of stock of certain lots of 1-day Acuvue Moist for Astigmatism lenses. If not already contacted, customers should return these lenses to their supplier. The affected lots may have particles on the contact lens or in the contact lens blister solution. If the particles are not noticed before insertion into the eye, this could cause eye redness or discomfort or corneal abrasion (damage to the surface of the eye). There have been no reports of serious adverse events to date.”
The MHRA confirmed that Johnson & Johnson Vision has “notified affected opticians and optometrists, recalling the affected lots, and has instructed them to contact patients who may have received the affected product.”
The agency advises that contact lens users who are concerned should speak to their optician or optometrist.
In its statement, the MHRA states that users of the contact lenses can check if their products are affected by looking at the lot number of the lens boxes against the list published by Johnson & Johnson Vision in the company’s field safety notice (FSN). Lot numbers are displayed on the back or side of each carton of 28 lenses, as well as on the foil cover of individual lenses.
MHRA group manager of device safety and surveillance, Mark Birse, commented: “While the risk is low, the MHRA takes the safety of the medicines and devices we regulate very seriously. It is therefore important that as many customers as possible are made aware of the need to check their lenses for these lot numbers. Contact lens users who still have concerns should contact their optician or optometrist. They can also report any adverse effects to the MHRA’s Yellow Card Scheme.”
A spokesperson at Johnson & Johnson Vision told OT: “Our top priority is patient safety and we hold ourselves to high standards for product quality and customer satisfaction. We are voluntarily recalling two full and one partial master lots of 1-day Acuvue Moist for Astigmatism contact lenses in Europe, the Middle East and Asia because they do not meet quality standards. The quantity of stock affected is low. We have identified the cause, taken corrective action, and are planning to implement even stronger manufacturing and quality controls based on learnings from this event. Acuvue brand contact lenses not impacted by this recall are safe when used as directed and can continue to be used with confidence.”
The spokesperson added that all customers in the UK with affected batches have now been contacted and the process of communicating with patients and returning the affected batches is underway. They stressed that a very small number of lenses were affected and there have been no reports of harm in the UK.
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