Recall of Intraocular lenses by manufacturer AMO
People who have received an intraocular lens through a transplant urged to seek urgent medical attention if they suffer discomfort after leading manufacturer issues recall
Posted on 13 September 2016
IOLs are medical devices which are implanted inside the eye to replace the eye's natural lens when it’s removed during cataract surgery. They are also used for a type of vision correction surgery called refractive lens exchange.
In August the Medicines and Healthcare products Regulatory Agency (MHRA), which regulates medicines and medical devices in the UK issued a Field Service Notice (FSN) to all doctors after the makers AMO issued a voluntary recall of AMO intraocular lenses.
According to the urgent product recall issued by AMO, the recall followed the detection of an inspection equipment malfunction that resulted in a total of 737 globally distributed lenses not being fully checked prior to release.
The malfunction may result in the release of mislabelled IOLs which could lead to potential unexpected postoperative refractive error and may result in a secondary surgical intervention.
Thomas Jervis, a lawyer in the Consumer Law and Product Safety group at Leigh Day who is representing a number of people who claim their IOL has caused them injury, said:
“We would urge anyone who has recently had an IOL procedure and is suffering any ill effects to contact their doctor straight away.”
The details of the FSN are: FSN2016-02 Voluntary Recall of AMO Intraocular Lenses, Model Numbers; ZCB00, PCB00, AR40e, ZLB00, ZXR00