TOPIC: enVista Aspire, enVista Envy and Certain enVista Monofocal Intraocular Lenses by Bausch + Lomb: Recall - Due to Increased Frequency of Reports of Toxic Anterior Segment Syndrome
AUDIENCE: Patient, Health Care Professional, Risk Manager, Ophthalmology
ISSUE: Bausch + Lomb Corporation is recalling intraocular lenses (IOLs) on its enVista platform. This action was taken after the company received reports of complications, the cause of which could not immediately be explained.
The recall is in response to an increased number of reports of toxic anterior segment syndrome (TASS), and includes all lots of the following enVista Aspire, enVista Aspire Toric, enVista Envy and enVista Envy Toric, as well as enVista monofocal and enVista monofocal Toric IOL models in the U.S.
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND: TASS, a potential complication in any cataract surgery, is an inflammatory reaction inside the eye that can have a variety of causes. When it occurs, this complication typically appears 12 – 48 hours after eye surgery. All enVista TASS cases reported to Bausch + Lomb to date responded quickly to treatment, and none have required removal of the lens.
RECOMMENDATIONS:
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For Patients: Cataract surgery patients experiencing eye discomfort should contact their eyecare professional immediately.
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For Eyecare Professionals: Please continue to closely monitor cataract surgery patients for at least 48 hours after surgery. Please instruct patients with new or worsening symptoms to contact your office immediately.
- To report an adverse event, please contact Bausch + Lomb Customer Service at 1-800-338-2020, option 1.
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