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Custom Surgical Pack Recall: Alcon Removes Custom Pak Ophthalmic Procedure Packs
The FDA is aware that Alcon has issued a letter to affected customers recommending the removal of certain Alcon Custom Paks from where they are used or sold. Alcon is recalling certain lots as they may contain pouches with incomplete seals, which would compromise the sterile barrier.
The use of non-sterile surgical products may increase the risk of microbial contamination and subsequent ocular infection which may necessitate additional medical attention.
As of December 18, Alcon has not reported any serious injuries or deaths associated with this issue.
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.
Questions?
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Alcon through https://notifeye.alcon.com/external/s/ or call 1-800-757-9780 and select option 5.
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