Bausch + Lomb recalls lenses used in cataract surgery due to inflammatory reactions
Bausch + Lomb has recalled lenses used during cataract surgery due to complications when the lenses are used, according to an announcement from the Canada-based eyecare company posted on the U.S. Food and Drug Administration's website.
The company recalled all lots of its enVista Aspire, enVista Aspire Toric, enVista Envy and enVista Envy Toric intraocular lenses. Also included are the enVista monofocal and enVista monofocal Toric lenses, the company said.
The company recalled the products after receiving an increased number of reports of toxic anterior segment syndrome (TASS), an inflammatory reaction of the anterior segment of the eye.
'This action was taken after the company received reports of complications, the cause of which could not immediately be explained,' Bausch + Lomb said in its announcement.
Brent Saunders, chairman and CEO, Bausch + Lomb, said in the announcement that patient safety is the company's main concern.
'Surgeons and patients trust Bausch + Lomb, and I believe that this voluntary recall is the best thing we can do to honor that trust,' Saunders said.
Read more: USA TODAY's recall database
What is an intraocular lens?
An intraocular lens, also called an IOL, is a small, artificial lens doctors surgically add to the eye. Doctors remove the eye's natural lens during surgery and then replace it with the intraocular lens, according to the American Academy of Ophthalmology.
The lens bends light rays that enter the eye, helping patients to see, the academy said. The natural lenses are clear but those suffering from cataracts have cloudy lenses. The cloudiness causes patients to have blurry, hazy or less colorful vision.
Doctors who treat these patients remove the cloudy lenses and replace them with the clear intraocular lenses like the ones Bausch + Lomb manufactures.
The intraocular lenses are made of silicone, acrylic, or other plastics and are coated in material to protect the eyes from the sun's ultraviolet rays. Similar to prescription glasses and contact lenses, intraocular lenses come in different strengths, the academy said.
According to the academy, intraocular lenses function in different ways to address a range of vision issues.
What lenses are recalled?
Recalled lenses include:
enVista Monofocal – All models starting with EE
enVista Aspire IOL – All models starting with EA
enVista Envy IOL – All models starting with EN
enVista Monofocal Toric IOL – All models starting with ETE
enVista Aspire Toric IOL – All models starting with ETA
enVista Envy Toric IOL – All models starting with ETN
What is toxic anterior segment syndrome?
Bausch + Lomb issued the recall after it received reports of toxic anterior segment syndrome, also called TASS, according to the announcement.
TASS is a complication in cataract surgeries that involves an inflammatory reaction inside the eye. The complication typically occurs 12 to 48 hours after eye surgery, the company said. The condition can be caused by detergents or disinfectants on surgical instruments, improperly mixed solutions, preservatives-containing medications injected into the eye, or endotoxins in intraocular lens implants, the company said.
According to the company, all enVista TASS cases reported to Bausch + Lomb were treated quickly and improved. None of these cases led to the lenses having to be removed.
'These reports represent only 1-2% of implanted lenses, with a positive prognosis for everyone involved,' Saunders said. 'We look forward to identifying a root cause and bringing the enVista platform back to market.'
What should I do if I am having complications?
The company said it is already communicating with eyecare professionals and recommends that they keep an eye on cataract surgery patients for at least 48 hours after surgery.
Patients who are having complications should contact their doctors immediately.
To report issues, contact Bausch + Lomb Customer Service at 1-800-338-2020, option 1, or submit a report to FDA's MedWatch program.
Saleen Martin is a reporter on USA TODAY's NOW team. She is from Norfolk, Virginia – the 757. Email her at sdmartin@usatoday.com.
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