Bausch + Lomb Announces Voluntary Recall of enVista Aspire™, enVista Envy™ and Certain enVista® Monofocal Intraocular Lenses
Bausch + Lomb (NYSE/TSX: BLCO) has announced a voluntary recall of its enVista platform intraocular lenses (IOLs), including enVista Aspire™, enVista Envy™, and certain enVista® monofocal models. The recall was initiated following reports of toxic anterior segment syndrome (TASS) complications in some patients.
TASS, an inflammatory reaction that typically manifests 12-48 hours post-cataract surgery, has been reported in a small percentage of implanted lenses. Chairman and CEO Brent Saunders emphasized that all reported TASS cases responded well to treatment, with no lens removals required. The company is prioritizing patient safety and is currently communicating with eye care professionals regarding impacted lots and return protocols while working to identify the root cause.
Bausch + Lomb (NYSE/TSX: BLCO) ha annunciato un richiamo volontario delle sue lenti intraoculari (IOL) della piattaforma enVista, inclusi enVista Aspire™, enVista Envy™ e alcuni modelli monofocali enVista®. Il richiamo è stato avviato dopo segnalazioni di complicazioni da sindrome del segmento anteriore tossico (TASS) in alcuni pazienti.
La TASS, una reazione infiammatoria che si manifesta tipicamente 12-48 ore dopo l'intervento di cataratta, è stata segnalata in una piccola percentuale di lenti impiantate. Il presidente e CEO Brent Saunders ha sottolineato che tutti i casi di TASS segnalati hanno risposto bene al trattamento, senza necessità di rimozione delle lenti. L'azienda sta dando priorità alla sicurezza dei pazienti e sta attualmente comunicando con i professionisti della cura degli occhi riguardo ai lotti interessati e ai protocolli di restituzione, mentre lavora per identificare la causa principale.
Bausch + Lomb (NYSE/TSX: BLCO) ha anunciado un retiro voluntario de su plataforma de lentes intraoculares (IOL) enVista, que incluye enVista Aspire™, enVista Envy™ y ciertos modelos monofocales enVista®. El retiro se inició tras informes de complicaciones por síndrome del segmento anterior tóxico (TASS) en algunos pacientes.
El TASS, una reacción inflamatoria que típicamente se manifiesta entre 12 y 48 horas después de la cirugía de cataratas, se ha reportado en un pequeño porcentaje de lentes implantadas. El presidente y CEO Brent Saunders enfatizó que todos los casos de TASS reportados respondieron bien al tratamiento, sin necesidad de extracción de lentes. La empresa está priorizando la seguridad de los pacientes y actualmente se está comunicando con profesionales de la salud ocular sobre los lotes afectados y los protocolos de devolución, mientras trabaja para identificar la causa raíz.
바우슈 + 롬 (NYSE/TSX: BLCO)은 enVista 플랫폼의 인공 수정체(IOL), 즉 enVista Aspire™, enVista Envy™ 및 특정 enVista® 단초점 모델에 대해 자발적인 리콜을 발표했습니다. 이 리콜은 일부 환자에서 독성 전방 섬유증(TASS) 합병증이 보고된 후 시작되었습니다.
TASS는 일반적으로 백내장 수술 후 12-48시간 이내에 나타나는 염증 반응으로, 이식된 렌즈의 소수에서 보고되었습니다. 브렌트 손더스 회장 겸 CEO는 보고된 모든 TASS 사례가 치료에 잘 반응했으며 렌즈 제거가 필요하지 않았다고 강조했습니다. 회사는 환자의 안전을 최우선으로 하며, 영향을 받은 로트와 반품 프로토콜에 대해 안과 전문가와 소통하고 있으며, 근본 원인을 파악하기 위해 노력하고 있습니다.
Bausch + Lomb (NYSE/TSX: BLCO) a annoncé un rappel volontaire de ses lentilles intraoculaires (IOL) de la plateforme enVista, y compris enVista Aspire™, enVista Envy™ et certains modèles monofocaux enVista®. Le rappel a été initié suite à des rapports de complications dues au syndrome du segment antérieur toxique (TASS) chez certains patients.
Le TASS, une réaction inflammatoire qui se manifeste généralement 12 à 48 heures après une chirurgie de la cataracte, a été signalé dans un petit pourcentage de lentilles implantées. Le président et PDG Brent Saunders a souligné que tous les cas de TASS signalés ont bien répondu au traitement, sans nécessité de retrait des lentilles. L'entreprise accorde la priorité à la sécurité des patients et communique actuellement avec des professionnels de la santé oculaire concernant les lots concernés et les protocoles de retour, tout en travaillant à identifier la cause profonde.
Bausch + Lomb (NYSE/TSX: BLCO) hat einen freiwilligen Rückruf seiner enVista-Plattform-Intraokularlinsen (IOL) angekündigt, einschließlich enVista Aspire™, enVista Envy™ und bestimmten enVista® monofokalen Modellen. Der Rückruf wurde nach Berichten über toxisches anterior segment Syndrom (TASS) Komplikationen bei einigen Patienten eingeleitet.
TASS, eine entzündliche Reaktion, die typischerweise 12-48 Stunden nach einer Kataraktoperation auftritt, wurde bei einem kleinen Prozentsatz der implantierten Linsen gemeldet. Der Vorsitzende und CEO Brent Saunders betonte, dass alle gemeldeten TASS-Fälle gut auf die Behandlung reagierten und keine Linsenentfernungen erforderlich waren. Das Unternehmen priorisiert die Sicherheit der Patienten und kommuniziert derzeit mit Augenpflegefachleuten über betroffene Chargen und Rückgabeverfahren, während es daran arbeitet, die Ursachen zu identifizieren.
- All reported TASS cases responded quickly to treatment
- No lens removals were required in affected cases
- Voluntary recall of multiple IOL product lines from enVista platform
- Increased reports of toxic anterior segment syndrome (TASS) complications
- Temporary market withdrawal of enVista platform products
“As much as we believe in the enVista platform, patient safety will always be our number one priority,” said Brent Saunders, chairman and CEO, Bausch + Lomb. “Surgeons and patients trust Bausch + Lomb, and I believe that this voluntary recall is the best thing we can do to honor that trust.”
The recall is in response to an increased number of reports of toxic anterior segment syndrome (TASS) in conjunction with implantation of enVista Aspire, enVista Envy and certain enVista monofocal IOLs.
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 responded quickly to treatment, and none have required removal of the lens.
“These reports represent an extremely small percentage of implanted lenses, with a positive prognosis for everyone involved,” Saunders continued. “We look forward to identifying a root cause and bringing the enVista platform back to market.”
Communications to eye care professionals are underway, with information on impacted lots and return protocols. Click here for a message from Saunders to customers, and here for a TASS fact sheet.
About Bausch + Lomb
Bausch + Lomb is dedicated to protecting and enhancing the gift of sight for millions of people around the world – from birth through every phase of life. Its comprehensive portfolio of approximately 400 products includes contact lenses, lens care products, eye care products, ophthalmic pharmaceuticals, over-the-counter products and ophthalmic surgical devices and instruments. Founded in 1853, Bausch + Lomb has a significant global research and development, manufacturing and commercial footprint with approximately 13,500 employees and a presence in approximately 100 countries. Bausch + Lomb is headquartered in
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Source: Bausch + Lomb Corporation
FAQ
What products are affected by Bausch + Lomb's (BLCO) 2024 recall?
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How serious are the TASS complications reported with BLCO's enVista lenses?
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When will Bausch + Lomb (BLCO) return enVista products to the market?
