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Bausch + Lomb has initiated a voluntary recall of several intraocular lens (IOL) products within its enVista platform, following reports of toxic anterior segment syndrome (TASS) in a small percentage of patients. The recall affects the enVista Aspire™, enVista Envy™, and specific enVista® Monofocal models currently distributed in the United States. Although the condition has reportedly responded well to treatment in all known cases, the company is acting out of caution as it investigates the root cause.
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The recalled lenses include various toric and monofocal models identifiable by specific model prefixes: “EA” for Aspire, “EN” for Envy, and “EE” for monofocal lenses, among others. According to the company, all lots of these models are being withdrawn. TASS is an inflammatory complication that can occur within 12 to 48 hours following cataract surgery. While the incident rate of the complication is estimated at 1–2% among affected lenses, Bausch + Lomb stated that no cases have required lens removal, and patients have shown positive recovery outcomes.
The company is actively reaching out to eyecare professionals with instructions for product return and patient monitoring guidelines. Patients who have recently undergone cataract surgery using any of the impacted products are advised to immediately report any eye discomfort. Healthcare providers are urged to monitor patients for at least two days post-surgery and respond promptly to any worsening symptoms.
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Bausch + Lomb emphasized its commitment to patient safety and its intent to restore the enVista line once the underlying issue is identified and resolved. In the interim, the company has made support resources and detailed recall documentation available to clinicians and patients. Reports of adverse events related to the affected lenses can be submitted to Bausch + Lomb directly or through the FDA’s MedWatch program.
Article by multiple RFHC contributors, based upon information from the FDA
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