According to the FDA, Bausch + Lomb/Synergetics Inc. has recalled four lots of its Bausch + Lomb I-Pack Injection Kit because officials are unable to verify the full sterilization of the products. Because of the risk of serious injury or death posed by the use of a potentially non-sterile product, the recall has been labeled Class I, the most serious type.
The following varieties of the product are affected:
- Bausch + Lomb I-Pack Injection Kit
- UDI/DI 20841305107544; Lot Number P62764979R
- Bausch +Lomb I-Pack Injection Kit with drape
- UDI/DI 20841305107551, Lot Number P63044983R
- Bausch +Lomb I Pack Injection Kit
- UDI/DI 20841305107605, Lot Number P62764965R
- Bausch+Lomb I-Pack Injection Kit
- UDI/DI 20841305107612, Lot Number P627664970R
Officials say those who use an affected product could experience a range of adverse health outcomes, which include major eye infections (endophthalmitis), loss of vision, total loss of an eye, and even death.
At the time of the July 15, 2024 FDA announcement, the company has not received any reports of related injuries or death. However, those who may have purchased an affected Bausch + Lomb I-Pack Injection Kit is asked to refrain from using it.
An Urgent Medical Device Voluntary Recall Notice was sent out to Bausch + Lomb/Synergetics customers on June 12, 2024, with the following recommended actions:
- Evaluate the institution/facility’s inventory for any of the above affected products. If one or more is identified, be sure to quarantine the items to prevent usage.
- Complete the Recall Acknowledgement Form included with the Recall Notice and have it submitted to the company.
- Read and heed the instructions outlined for affected products on the Recall Acknowledgement Form.
- Ensure that the letter and acknowledgement form is forwarded to anyone or any institution that may have received a sub-distribution of the product.
U.S. customers with recall-related questions and concerns may reach out to either a Bausch + Lomb sales representative or a customer service team member at (800) 338-2020.
As the FDA continues to monitor this recall, healthcare professionals and consumers are encouraged to report any adverse outcomes or quality issues to the agency’s MedWatch program.
If you have suffered an injury or illness as a consequence of using a compromised or non-sterile medical drug, we would like to help you pursue maximum compensation. Our experienced attorneys at TruLaw make it a mission to protect the rights of consumers like you and ensure that negligent parties are held responsible. We are prepared to learn about your case and begin supporting you. Reach out online or try out our free Instant Case Evaluation ℠.