Bausch + Lomb Corporation announced a voluntary recall of intraocular lenses (IOLs) included in its enVista platform due to an increase in reports of complications over the last few weeks.
Let’s start with these products.
As one of B+L’s IOL brand platforms, the enVista product line features FDA-approved monofocal and toric hydrophobic acrylic IOLs crafted with unique features and proprietary technologies.
Included in the lineup:
- MX60E, MX60PL (monofocal)
- MX60ET, MX60PT (toric)
- enVista Aspire (toric and monofocal)
- enVista Envy (toric and non-toric)
Now to this recall.
The why: B+L reported the move was made in response to an increase in reports of toxic anterior segment syndrome (TASS) connected to implantations of specific enVista lenses across the United States.
Those lenses: Included the enVista Aspire and enVista Envy IOLs as well as “certain enVista monofocal lenses" which include models starting with EE (non-toric monofocal) and ETE (toric monofocal).
- As we noted above: The Aspire and Envy are the two newest additions to the enVista platform, with the Envy receiving FDA approval just last October.
And take note: This recall does not impact the MX lenses.
Circle back and explain TASS.
TASS is an acute sterile inflammatory reaction in the anterior segment that can develop 12 to 48 hours—or even weeks in delayed-onset situations—following intraocular surgery (typically cataract surgery).
Most notably: The reaction can mimic chronic inflammatory responses similar to those seen in infectious endophthalmitis.
How is it diagnosed?
Through a full eye examination of a patient’s VA, pupil size and reaction, slit-lamp evaluation, as well as intraocular pressure (IOP) and dilated fundus exam.
As for signs and symptoms, these may include (among others):
- Vision loss or blurry vision
- Mild to severe pain
- Photophobia (light sensitivity)
- Corneal edema extending from limbus to limbus
- Dilated or irregular pupil
- Increased IOP
What may cause its development?
An inflammatory reaction like this could be in response to any number of factors: contamination, toxins, imbalanced solutions, and even medications or preservatives in medications.
In cataract surgery: TASS could develop as a result of non-fectious substances entering the anterior chamber—often due to contamination from surgical equipment or supplies.
And how is it usually treated?
Topical steroids are the typical go-to route. However, in rarer cases (and depending on the severity of the reaction), systemic steroids or surgical intervention may be needed.
So what do we know about these enVista-related cases?
To start: The root cause for the recall remains “unclear,” per a message from B+L CEO Brent Saunders.
However: In a letter to eyecare professionals (ECPs), Saunders stated that the TASS reports were originally linked to just the enVista Envy IOL before expanding more recently to the enVista Aspire and monofocal lenses.
How about specifics on these reported cases?
While B+L didn’t go into specifics on the number or severity of TASS cases that were reported, Saunders emphasized that “all reported enVista TASS cases responded quickly to treatment and did not result in removal of the (implanted) lens.”
- He added: “Only a handful involved intervention beyond standard of care.”
That’s good to hear. But then why the need for a recall?
Quite simply: An abundance of caution.
Despite these TASS reports “(representing) an extremely small percentage of implanted lenses, with a positive prognosis for everyone involved,” Saunders stated that the products will be kept off the market while the company works to identify and address the root cause.
And how is it doing that?
Through ongoing testing of multiple lots and types of lenses and analyzing reports for potential patterns or common factors.
Saunders also shared that B+L has gathered a group of cataract specialists to "understand their perspectives and help us chart the best path forward.”
So what’s next in the meantime?
The company is asking ECPs to report any adverse events or complaints related to B+L’s products by contacting their Customer Care team: (800) 338-2020, option 9.
And stay tuned for more details on this situation.