Bausch & Lomb Surgical, Inc. is recalling 285,077 units of enVista Aspire, enVista Envy, and certain enVista Monofocal intraocular lenses. These medical devices, which are implanted in the eye during surgery, were recalled following an increased number of reports of Toxic Anterior Segment Syndrome (TASS) in the United States. TASS is a serious sterile inflammation of the front part of the eye that occurs after surgery. Healthcare providers and surgical centers should contact the manufacturer or their distributor immediately to coordinate the return and replacement of any unused lenses from the affected lots.
The use of these recalled lenses can lead to Toxic Anterior Segment Syndrome (TASS), which causes sudden inflammation in the eye shortly after surgery. This condition can result in eye pain, redness, and a decrease in vision, requiring further medical intervention to manage the inflammation and protect the patient's eyesight.
Clinical Correction and Return
Recall #: Z-1679-2025. Quantity: 236,840 units.
Recall #: Z-1680-2025. Quantity: 48,237 units.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · FDA Press Release · Raw API Response
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