The recall of contact lens rinse solutions and cleaning products did not make the news a few months ago when SA’s dominant supplier, Bausch + Lomb, issued a statement saying it was recalling a wide range of products “voluntarily” and as a “precaution”. Most contact lens wearers would have only realized there was a problem when they couldn’t find the solutions they needed.
The root of the problem was the sterilization of bottles, bottle caps and caps by one of the suppliers in the Bausch + Lomb supply chain of these packaging materials.
“Bausch + Lomb, a leading global eye health company, is recalling certain batches of Biotrue Multi-Purpose Solution, Boston Advance Cleaner, Boston Advance Conditioning Solution, Boston Simplus Multi-Action Solution, EasySept Peroxide Solution, LensLubricant, ReNu Multi -Solution of purpose, ReNu MultiPlus Solution and Saline Plus Solution that were manufactured at its facilities in Milan, Italy, ”the company said in a statement issued on May 24.
‘Low risk of infection’
He added: “While there is a low risk of infection with these products, we have chosen to voluntarily recall these product batches because we cannot confirm the supplier’s compliance with the process compliance requirements for some of the components of these products.
“To date no serious adverse events have been reported in association with this problem,” the company said in its statement.
Documents related to the recall address data and certification issues. “The external company that supplies some of the components of our products notified Bausch + Lomb of data integrity issues with their sterilization certificates. These certificates are provided to Bausch + Lomb by this third-party supplier to demonstrate that the components of each batch are properly processed and sterilized.
“Upon receiving notification of this information, Bausch + Lomb promptly began a comprehensive investigation,” the document reads, once again saying that there was only a low risk of eye infection.
The third-party sterilization process is a part of the contact lens solution manufacturing process. This part of the process is designed to remove bacteria or other live microorganisms from certain components before their use in production, according to the information contained in the documents.
“The entire manufacturing and quality control process of these products is completed with an evaluation of the sterility of the product. No product launched on the market with the affected components has failed sterility tests, ”says Bausch + Lomb, adding once again that the risk of infection is low and that the recall was done voluntarily and was not ordered by any regulatory authority.
Severity of the situation
However, the problem appears to be more serious than this suggests, for different reasons.
The most important thing is that the human eye is a very fragile, complicated and sensitive small organ. The view is irreplaceable.
For Bausch + Lomb, a small problem with sterilization could quickly turn into a costly and potentially ruinous legal action.
The scope of the recall also points to the severity of the problem.
“This voluntary recall is taking place in Europe, Middle East, Africa, Russia / CIS [Commonwealth of Independent States], Hong Kong and China, ”the company said.
We should note that that includes almost half the world.
The company also immediately put in place a procedure whereby optometrists and consumers could return affected products for a full refund, even if consumers did not have the original sales invoice or receipt for the products.
One major concern is that the recall only came a few months after Bausch + Lomb became aware of the “data integrity and certification” issue.
The problem with the certificates that guarantee that everything is done correctly at the bottle manufacturer arose in February, while the recall took place three months later, towards the end of May.
An internal document to guide employees in answering questions states that “the assessment that our products have a low risk of infection despite this component-related issue gave us time to conduct a thorough investigation.”
“Investigating the situation with this supplier was complex and required the review of a large amount of technical data. At the end of the investigation, Bausch + Lomb decided to proceed with a voluntary recall due to our inability to confirm the supplier’s compliance with the process compliance requirements for the affected batches, ”he said.
Another sign that things were perhaps more serious than a simple problem with a few pieces of paper is that Bausch + Lomb immediately disqualified the particular supplier as a sterilizer of its components and appointed a new company to sterilize the bottles, caps and inserts.
He warned that switching to a new supplier would affect product availability through September 2021.
The local Bausch + Lomb representative indicated that contact lens solutions, cleaners and lubricants should be available again in South Africa from mid-September.
Bausch + Lomb assured users that it took corrective action. That:
- Stopped using this vendor to sterilize the components of these products,
- Stopped product launch and shipping,
- Disqualified this vendor as a third-party vendor,
- Qualified Alternative Sterilizer,
- Increased verification of data integrity in your supplier audit, and
- A recall of the affected products was initiated.
Inconvenient moment for the company
Meanwhile, this mess couldn’t have come at a more inopportune time for Canadian holding company Bausch Health.
It recently started a process to separate Bausch + Lomb’s eye health division and list it separately.
A few weeks before the big product recall, Bausch said things were on track to list the spin-off in October this year.
In early August, the company said nothing about the recall when it announced its quarterly earnings and references to the Bausch + Lomb listing did not mention a firm date.