The Medicines & Healthcare products Regulatory Agency (MHRA), which regulates the safety of medical devices in the UK, has issued an urgent Field Safety Notice, advising that Abbott Medical Optics (AMO), a manufacturer of ophthalmic medical devices, has voluntarily recalled a number 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 AMO has recalled the lenses after detecting an “inspection equipment malfunction that resulted in a total of 737 globally distributed lenses not being fully checked prior to release”. It goes on to say that, if a patient has been fitted with an incorrect lens, they may experience problems with their vision which could result in further surgery.
AMO has confirmed that there may be problems with the following IOLs:
- Tecnis Symfony IOL (Model ZXR00)
- Sensar Acrylic IOL (Model AR40e)
- Tecnis iTec Preloaded 1-Piece IOL (Model PCB00)
- Tecnis Multifocal 1-Piece IOL (Model ZLB00)
- TECNIS Monofocal 1-Piece IOL (Model ZCB00).
Arran Macleod, a solicitor in the Penningtons Manches product liability team, 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 AMO 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 advise anyone who feels that they have been adversely affected."