MHRA issues warning over intraocular lenses

Posted: 27/09/2017

The Medicines and Healthcare products Regulatory Agency (MHRA), which regulates the safety of medical devices in the UK, has issued an urgent notice advising that Carl Zeiss Meditec, a manufacturer of ophthalmic medical devices, has voluntarily recalled a small batch of its intraocular lenses (IOL).

IOLs are artificial lenses, usually made of plastic, silicone or acrylic. They are commonly fitted during cataract surgery to replace the eye’s natural (but cloudy) lens. They are also used during vision corrective surgery, known as refractive lens exchange.

The urgent notice explains that the lenses have been recalled after Carl Zeiss Meditec detected a “potential labelling error that resulted in a total of three units being mislabelled with the wrong dioptric power”. It goes on to say that, if a patient has been fitted with an incorrect lens, they may experience “myopic or hyperopic post-operative refractive outcomes, and potential explantation of the lens”.

Carl Zeiss Meditec has confirmed that there may be problems with its Aaren Scienfific EC-3 hydrophobic lens with a +10.0 diopter. Products with the following serial numbers are affected:

• 3S1605000024
• 3S1605000026
• 3S1605000027 

Arran Macleod, a solicitor in the product liability team at Penningtons Manches, said: “The fact that some patients may have been fitted with an incorrect IOL as a result of a manufacturing fault is not acceptable. Patients are often worried about the prospect of eye surgery and, if they have been given an incorrect lens, they may need to undergo a further procedure, causing additional stress and anxiety.

“Anyone who has been fitted with an EC-3 hydrophopbic lens, and has concerns, should contact their GP or treating doctor for advice. As a product liability team, we will be monitoring the situation and can assist anyone who feels that they have been adversely affected."

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