Voluntary recall January 2016
Posted on 6/01/2016
Since 1950 Rayner has been known for high levels of product quality, a record of which we are proud. Our own internal limits are often set in excess of those demanded by regulatory bodies; one such example is aluminium oxide (used for polishing IOLs) for which we set stringent internal limits even though none are specified by the relevant international ISO standards. Unfortunately, there is a possibility that certain products released to market since 11th November 2015 may contain levels of this compound that slightly exceed these self imposed limits. This potentially affects non-US products released during this period. We have taken steps to quarantine the vast majority of affected products but some 2,400 lenses were released to market across a small number of hospitals. As a precaution, and because clinically significant levels of aluminium oxide have, on rare occasions been linked to cases of Toxic Anterior Segment Syndrome (TASS) in published literature1, Rayner has initiated a voluntary recall of these products effective 30th December 2015.
All affected parties have already been contacted individually in order to replace the products concerned along with details of corrective actions.
I would like to stress that the risks are extremely low. Historically, cases where Rayner lenses have been used and TASS subsequently reported are negligible, in fact for 2015 these cases accounted for less than 0.0005 % of all lenses sold. This is, therefore, a precautionary step in line with our values of openness and integrity, first and foremost to patients. I sincerely apologise for this failure. We all aim for perfection and on this occasion we fell short.
Chief Executive Officer
1Don Calogero, MS et al; Evaluation of Intraocular Reactivity to Metallic and Ethylene Oxide Contaminants of Medical Devices in a Rabbit Model; Ophthalmology 2012;119:e36–e42