In April 2025, Bausch + Lomb (B+L) initiated a voluntary recall of certain intraocular lenses (IOLs) in the United States in Late March, and this applies to Canada.[1] The recall came following reports of an inflammatory condition known as Toxic Anterior Segment Syndrome (TASS), This recall underscores the importance of vigilance in medical device safety and the need for timely legal and medical responses when adverse events occur.
What Is TASS and Why Is It a Concern?
As per B+L’s handout regarding TASS, it is an inflammatory reaction that can develop after eye surgery, typically due to the introduction of toxic substances into the eye. While not an infection, TASS can lead to symptoms such as redness, swelling, pain, clouded vision, and increased eye pressure, potentially resulting in glaucoma or permanent vision loss if not promptly treated. In the case of the affected IOLs, the exact cause of TASS remains unclear, prompting the recall until further investigation clarifies the issue.
Affected Products
The recall affects the following Bausch + Lomb IOL models:
- enVista monofocal lenses (model numbers beginning with EE and ETE);
- enVista Envy; and
- enVista Envy Toric lenses
Patients who have received these lenses are advised to consult their ophthalmologists to assess any potential risks and to determine appropriate monitoring or treatment.
Legal Implications for Patients and Healthcare Providers
For patients, the recall may raise concerns about the safety and efficacy of their implanted lenses. In the event of adverse reactions, patients may have legal avenues to pursue compensation for medical expenses, pain and suffering, or other related damages. It is crucial for patients to document all symptoms, treatments, and communications with healthcare providers to support any potential claims.
Healthcare providers must also be proactive in addressing the recall. This includes notifying affected patients, monitoring for symptoms of TASS, and reporting any adverse events to Health Canada. Failure to adhere to recall protocols or to provide timely care could expose healthcare providers to legal liability.
Steps to Take
If you are a patient who has received an affected IOL, consider the following steps:
- Contact your ophthalmologist to discuss the recall and any necessary evaluations;
- Monitor for any symptoms of TASS and seek immediate medical attention if they occur;
- Keep detailed records of all medical visits, treatments, and communications related to the recall; and
- Consult with a legal professional to understand your rights and potential for compensation.
For healthcare providers, ensure that you are fully informed about the recall, communicate effectively with affected patients, and comply with all regulatory requirements to mitigate legal risks.
Conclusion
The recall of Bausch + Lomb IOLs serves as a reminder of the complexities involved in medical device safety and the critical role of legal guidance in navigating such situations. Patients and healthcare providers alike must remain vigilant and informed to ensure the best possible outcomes.
If you have been injured by a product that has a recall, please contact JEWELL RADIMISIS JORGE LL.P at 1-844-DIAL JRJ and a member of our team will be happy to provide you with a FREE consultation.
[1]https://www.cp24.com/news/canada/2025/04/10/lenses-used-in-eye-surgeries-recalled-until-company-knows-exactly-whats-going-on-ceo-says/