Bausch + Lomb is currently communicating with eye care professionals. Credit: ©2025 Bausch + Lomb.

博士伦目前正在与眼科护理专业人士沟通。图片来源：©2025 博士伦。

Bausch + Lomb has reported a “voluntary recall” of certain intraocular lenses (IOLs) on its enVista platform due to complications.

由于出现并发症，博士伦报告称其enVista平台上的某些人工晶状体（IOL）“自愿召回”。

This decision was made following an increase in the number of toxic anterior segment syndrome (TASS) cases reported in the US, which are associated with the implantation of enVista Envy IOLs, enVista Aspire, and some enVista monofocal lenses.

在美国，与植入enVista Envy人工晶状体、enVista Aspire以及部分enVista单焦点人工晶状体相关的毒性前节综合征（TASS）病例报告数量增加后，做出了这一决定。

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According to the company, TASS is an inflammatory reaction within the eye that can arise from several causes and usually manifests within 12 to 48 hours post-eye surgery. This condition is also stated to be a cataract surgery complication.

根据公司说法，TASS 是眼内的一种炎症反应，可能由多种原因引起，通常在眼部手术后 12 至 48 小时内出现。该状况还被描述为白内障手术的并发症。

Bausch + Lomb noted that all reported instances of TASS related to its enVista have been responsive to treatment, with no cases necessitating lens removal.

博士伦公司指出，所有报告的与enVista相关的TASS病例都对治疗有反应，没有需要取出晶状体的病例。

The company is currently communicating with eye care professionals to provide details on the affected lots and the protocols for returning.

公司目前正在与眼科护理专业人士沟通，以提供有关受影响批次的详细信息以及退货协议。

Bausch + Lomb CEO and chairman Brent Saunders said: “As much as we believe in the enVista platform, patient safety will always be our number one priority. Surgeons and patients trust Bausch + Lomb, and I believe that this voluntary recall is the best thing we can do to honour that trust.”

博士伦总裁兼董事长布伦特·桑德斯表示：“尽管我们相信enVista平台，但患者安全始终是我们的首要任务。外科医生和患者信任博士伦，我相信这次自愿召回是我们为维护这种信任所能做的最好的事情。”

“These reports represent an extremely small percentage of implanted lenses, with a positive prognosis for everyone involved. We look forward to identifying a root cause and bringing the enVista platform back to market.”

“这些报告仅代表极小比例的植入晶状体，所有相关人员的预后均良好。我们期待找到根本原因，并将enVista平台重新带回市场。”

Last May, the company

去年五月，该公司

announced the receipt

宣布收到

of Health Canada’s regulatory approval for the enVista Envy full visual range IOL.

加拿大卫生部对enVista Envy全视觉范围人工晶体的监管批准。

In October 2023, the company launched the enVista Aspire monofocal and toric IOLs with Intermediate Optimised optics in the US.

2023年10月，该公司在美国推出了具有中距离优化光学的enVista Aspire单焦点和散光人工晶状体（IOL）。

Founded in 1853, Bausch + Lomb has a portfolio of 400 products spanning eye care, contact lenses, ophthalmic pharmaceuticals, ophthalmic surgical devices, and instruments, as well as over-the-counter products.

成立于1853年的博士伦拥有涵盖眼镜护理、隐形眼镜、眼科药物、眼科手术设备和仪器以及非处方产品的400种产品组合。

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