22 January 2019

Oculentis intraocular lens recall

Read our statement on recent press articles about people who have experienced deterioration in their vision related to a batch of intraocular lenses.

You may have seen various articles in the press last week about people who have experienced a deterioration of their vision relating to a batch of intraocular lenses. Those affected typically experience a deterioration of visual acuity at around 36 months post-surgery, calcification of the IOL surface may be observed. Around 800 people are thought to be affected. The manufacturer claims the problem may be due to an interaction between phosphate crystals used in the hydration process and silicone residues on the lens. Oculentis says there is evidence some people may be predisposed to this problem or that certain medications can be a factor. 

We have recommended that any patients affected by a reduced visual acuity contact their optometrist for further advice to make a differential diagnosis. The manufacturer states that the opacification of the IOL may present biomicroscopic aspects similar to posterior capsular opacification and they recommend careful examination to determine the nature and location of the clouding. If presented with atypical cases of IOL implant surface opacification, follow your local protocol to refer the patient back to the cataract clinic which performed the surgery. The ophthalmologist will be able to advise on the best course of action and whether IOL exchange is an option.  An incident rate of 0.32% has been supplied by the manufacturer with a mean incubation time of 38 months, SD+/-9 months. Optometrists should be cautious about providing a prognosis or stating the exact cause of the opacification. The MHRA issued a recall in 2017.

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