Update Statement from the Irish Medicines Board on the Recall of Bausch and Lomb ReNu MoistureLoc Multi-Purpose Solution
15 May 2006
The Irish Medicines Board (IMB) can today confirm that Bausch and Lomb have issued a voluntary product recall to permanently remove the following contact lens solution, ReNu with MoistureLoc Multi-Purpose, from the worldwide market. The decision has been taken following an investigation by Bausch and Lomb which led them to suspect that a certain aspect of the MoistureLoc formula may increase the relative risk of Fusarium infection, a form of eye infection. To date there have been no confirmed reported incidents of Fusarium keratitis in Ireland.
The recall applies to all batches of Bausch and Lomb manufactured ReNu with MoistureLoc Multi-Purpose Contact Lens Solution currently on the Irish market and consumers are being advised to switch to an alternative contact lens care solution.
The IMB recommends that contact lens wearers adhere to the following recommendations:
- Immediately stop using the ReNu with MoistureLoc Multi-Purpose Contact Lens Solution
- Discard all remaining ReNu MoistureLoc solution and return the bottle to your eye care practitioner / optician to exchange it for an alternative lens care solution
- Consult your eye care professional / optician concerning use of an appropriate alternative cleaning / disinfectant product
- Continue to follow lens care practices as advised by your eye care professional / optician
The IMB are advising pharmacies and retail outlets stocking the affected Bausch and Lomb contact lens solution to immediately cease sales of the product ReNu with MoistureLoc Multi-Purpose. Retailers should conduct the recall as outlined by Bausch and Lomb and should contact the company to obtain details of the recall action if not already notified.
Healthcare professionals / clinicians with patients presenting with possible eye infections should consider fungal infections as a potential causative organism, investigate accordingly, retain contact lenses and solutions for analysis, refer the patient if appropriate, and report contact lens related infections to the manufacturer.
This action is being taken as part of a global product recall by Bausch and Lomb. The IMB will continue to monitor this issue closely and will maintain close communication with Bausch and Lomb and other regulatory agencies.
Bausch and Lomb have established a free phone number for Irish customers 1800 409077 and further information can be obtained from the Bausch and Lomb website www.Moistureloc.eu (www.bausch.com).
Avril Collins / Angie Grant
Tel: (01) 6760168 or
Weber Shandwick FCC 086 3964368 / 086 3772791