This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.
Affected Product (Include the following information)
- Product Name: Bausch + Lomb I-Pack Injection Kits
- Unique Device Identifiers (UDI)/Lot Numbers:
- 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.
What to Do
- Do not use affected Bausch + Lomb I-Pack Injection Kits.
On June 12, 2024, Bausch + Lomb/Synergetics Inc. sent an Urgent Medical Device Voluntary Recall Notice to customers recommending the following actions:
- Review inventory and isolate affected products to prevent unintended use.
- Complete and submit the Recall Acknowledgement Form enclosed with the letter.
- Follow the instructions for affected product that are included on the Recall Acknowledgement Form.
- Notify anyone who may have received affected product by forwarding the letter and acknowledgement form.
Reason for Recall
Bausch + Lomb and its subsidiary, Synergetics Inc., is recalling certain lots of I-Pack Injection Kits after being unable to verify that the products were fully sterilized.
The use of affected product may cause serious adverse health consequences, including serious eye infections (endophthalmitis), vision loss or total loss of the eye, and death.
There have been no reported injuries or reports of death.
Device Use
The Bausch + Lomb/Synergetics Inc. I-Pack Injection Kit is used to deliver medication into the eye (intravitreal injection).
Contact Information
Customers in the U.S. with questions about this recall should contact their Bausch + Lomb sales representative or the customer service team at (800-338-2020).
Additional FDA Resources
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
