The following notice appears on the Bausch + Lomb website.
Bausch + Lomb announces voluntary recall of certain lots of contact lens solutions, eye wash and eye lubricants
There are no known serious adverse events related to this recall.
Bausch + Lomb, a leading global eye health business, is conducting a voluntary recall of certain lots of various products that were manufactured at its facility in Milan, Italy.
This voluntary recall is being conducted in Europe, Middle East, Africa, Russia / CIS, Hong Kong and China, although the certain lots of Ophtaxia eye wash solution are only applicable to France and Hong Kong, and Sensitive Eyes eye lubricant solution to Hungary, Bulgaria and South Africa. Additionally, the only product being recalled in China is Boston Simplus Multi-action contact lens solution.
This voluntary recall follows a notification received by Bausch + Lomb from one of its third-party suppliers in Milan, Italy, which sterilizes some components (bottles, plugs and caps) of these products prior to manufacturing in our facility in Milan, Italy, of a compliance issue with its sterilization process. Bausch + Lomb is one of many companies impacted by this situation.
The health and safety of everyone who uses our products is our utmost priority. While there is a low risk of infection with these products, we have chosen to voluntarily recall these certain lots of products because we cannot confirm the supplier's conformance to process compliance requirements for some of the components of these products. No serious adverse events have been reported to date in association with this issue.
A complete list of the Bausch + Lomb products and lots impacted by this recall is below.
Product details
Expiration dates (all products): May 2021 - February 2024
Images are examples only. The products or packaging of these products may differ depending on the region / country.
Biotrue multi-purpose solution (60 ml, 240 ml, 300 ml)
Biotrue multi-purpose solution flight pack (60 ml, 2 x 60 ml)
Biotrue multi-purpose solution (2 x 300 ml, 4 x 300 ml)
ReNu MPS multi-purpose solution sensitive eyes (60 ml, 120 ml, 240 ml)
ReNu MPS multi-purpose solution sensitive eyes flight pack (60 ml, 2 x 60 ml)
ReNu MPS multi-purpose solution sensitive eyes (3 x 360 ml, 4 x 240 ml)
Boston SIMPLUS Multiaction Solution (120 ml, 4 x 120 ml)
Boston Multi Action Solution Special Flight Pack SIMPLUS (2 x 60 ml)
ReNu MultiPlus multi-purpose solution fresh lens comfort (60 ml, 240 ml, 3 x 360 ml, 4 x 240 ml)
Boston / Boston ADVANCE Cleaner (30 ml,4 x 30 ml)
Boston / Boston ADVANCE Conditioning Solution (120 ml and 4 x 120 ml)
Boston ADVANCE Cleaner Conditioning Solution Multipack (1 x 120 ml+ 1 x 30 ml)
Boston ADVANCE Cleaner Conditioning Solution Starter Kit ADVANCE FORMULA (1 x 30 ml + 1 x 10 ml)
Sensitive Eyes contact lens solution plus Saline (500 ml)
EasySept contact lens solution (120 ml, 360 ml, 3 x 360 ml)
Boots Pharmaceuticals Contact Lens Solution (240 ml)
Boots Pharmaceuticals All in One Solution (60 ml, 240 ml, 360 ml, 2 x 360 ml)
Boots Pharmaceuticals Advanced Conditioning Solution (120 ml)
Boots Pharmaceuticals Advanced Cleaning Solution (30 ml)
Boots Pharmaceuticals Enhanced All in One Solution (360 ml)
Boots Pharmaceuticals Advanced Cleaning and Conditioning Solutions (3 x 120 ml + 3 x 30 ml, 1 x 60 ml + 1 x 15 ml)
Specsavers easyvision ultrapurpose MPS (60 ml, 3 x 240 ml)
Affected product lot information can be located at BLRecall.expertinquiry.com. No other Bausch + Lomb products or lots are affected by this recall.
Consumers who may have these affected products in their possession should take the following steps:
1. Visit BLRecall.expertinquiry.com to verify the product is impacted.
2. If the product is impacted, stop using the product.
3. Register for further instructions at BLRecall.expertinquiry.com.
4.After following all instructions, discard the impacted product.
For more information on the recall, for assistance with registration or to report an adverse event or complaint, consumers should contact Sedgwick, the firm conducting this product recall on behalf of Bausch + Lomb, via email: BLRecall@Sedgwick.com, phone: 0800 949 6309 between the hours of 09:00 to 18:00 local time, Sunday -Saturday, or online at BLRecall.expertinquiry.com. Consumers should also contact their eye care professional for further care and instruction related to an adverse event.
Retailers, pharmacies, eye care professionals, distributors and wholesalers who have purchased products directly from Bausch + Lomb are asked to contact Sedgwick at + 0800 949 6309 to arrange for pick up of the identified product and for 'return material authorisation' instructions. If the products were not purchased directly from Bausch + Lomb, customers are asked to contact their re-seller to return the product and discuss exchange or refund options.
© 2024 itsa Ltd.