CooperVision initiated a recall of over thousands of Sofmed Breathables Advanced Toric contact lenses late last month. Just a few days ago, the FDA labeled it as a Class II recall.
Let’s start with this lens.
The product in question: Sofmed Breathables Advanced Toric (fanfilcon A) soft contact lens.
Manufactured by CooperVision, this is a toric silicone hydrogel (SiHy) lens indicated for daily wear with frequent replacement.
- The lens itself: is made with a 55% water content
Now to the recall.
CooperVision notified customers of the recall for this lens on Sept. 22.
- The official reason from the FDA: labeling design
But more specifically: The impacted lenses were noted as bearing "an incorrect statement on the carton packaging indicating that the product is ‘Indicated for Extended Wear’.”
… and that's not accurate, right?
Correct. As we mentioned, the product is intended for daily wear. The federal agency noted that this “extended-wear statement should not have appeared on the affected carton labeling.”
Why? The FDA has not approved the lens for extended wear use.
See here for the specific 510(K) numbers for the affected lenses.
Noted. So how many lenses are included in this recall?
To be extremely specific: 230,856 lenses distributed across three states: Florida, Kentucky, and Michigan.
Do we know which lot numbers?
Indeed we do. See here for the lengthy list.
Next up: this Class II level classification—what does it mean?
This FDA-assigned classification was added to the open recall on Oct. 22.
In general: A Class II designation translates to a situation in which the “use of or exposure to a violative product” could potentially cause:
- Temporary or medically reversible adverse health consequences
- A remote probability of serious adverse health consequences
In general: Providing a manufacturer has not issued a separate guidance suggesting otherwise, this FDA classification does not usually require consumers to immediately stop the use of an affected product.
And in this specific situation?
Customers are advised to:
- Stop any further use or distribution of products from the designated lot number(s) if the product packaging bears the Indicated for Extended Wear statement
- Return the product to their authorized distributor or eyecare provider (ECP).
- Contact their authorized distributor, ECP, or purchase location for any questions or assistance regarding product return, credit, or replacement (if necessary).
And for ECPs?
The FDA advises that they contact patients who have received the affected product and instruct them to return any affected product to their purchase location.
So, have there been any reports of adverse reactions?
Not as far as we can tell—at least, the FDA didn’t indicate any in its recall report.
But moving forward: If any consumers or ECPs do have adverse events to report, they should submit a form online via the FDA’s MedWatch Adverse Event Reporting program or by mail/fax.
Lastly: Isn’t there another ongoing CooperVision-related recall?
Indeed there is. Just over 3,000 of the company’s Pearle Vision 1 day contact lenses are part of a Class II recall initiated in August (and labeled by the FDA in September) due to an “incorrect power.”
- See here for more on this, including which states the lenses were distributed in.