Claims for compensation re defective Oculentis Intraocular lenses: 2017 update
Posted on 27th October 2017
In December 2014, the multinational pharmaceutical corporation, Oculentis, issued an urgent field safety notification and recall of its intraocular lens product known as the LENTIS HydroSmart intraocular lens.
The intraocular lens is a prosthetic lens which is inserted into the eye during surgery. This is commonly done in cataract surgery. Some ophthalmic retailers have also induced consumers to have lens replacement due to perceived benefits of being ‘glasses-free”. These lenses are supposed to be very long lasting and at least as long as the life expectancy of the patient.
A number of consumers who had these Oculentis lenses have found that after a year or two their prosthetic lens has gradually become cloudy. The cause of the cloudiness has subsequently been identified that calcium has become deposited on the lens, causing a gradual loss of vision in the affected eye.
The original December 2014 voluntary recall by Oculentis it was said:
“Analysis suggests a possible interaction between phosphate crystals originating from the hydration process of the IOL material and the fluctuating, batch related presence of silicone residues on some IOL’s. According to relevant literature, such residues may potentially change the IOL surface properties, making it under certain medical conditions more prone to deposition of calcium phosphate from the aqueous humor in predisposed patients. These deposits may compromise the optical transparency of the IOL, potentially leading to a reduction in the patient’s visual acuity.”
Since my comments in 2015, I have been contacted by and assisted a number of consumers who are affected by this issue to secure compensation. Many of them have been losing their sight due to this calcification of their lenses and requiring revision surgery. In some cases such surgery is not possible and loss of vision is permanent.
In September 2017, Oculentis issued a further Field Safety Notice. This applies to all LENTIS foldable Intraocular lenses with model numbers starting with L-, LU- and LS- and having an expiry date between January 2017 and May 2020.
The 2017 notice reveals the findings of Oculentis’ own investigation into the issue. It says they have clearly established the cause of the increase rate of lens failure is due to a phosphate-containing cleaning agent previously used in their production process, which could make the prosthetic lens more prone to opacification. They eliminated this process in June 2015 so are at pains to establish their lenses produced since that date are unaffected by the issue.
The September 2017 Field Safety Notice would appear to strengthen the claim that the lenses which have suffered opacification due to calcification are defective due to contamination in the manufacturing process. Oculentis have already established a scheme to enable further revision surgery without charge. However consumers are entitled to further compensation to reflect having to have unnecessary surgery and all the consequent losses associated with that including any loss of earnings, cost of medication/medical treatment, travel or other expenses.
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