FDA-Device2022-11-09Class II

BAUSCH + LOMB BASIC OPHTHALMIC PACK, REF LYN023BSBLB. Convenience kit used in surgical procedures.

MEDLINE INDUSTRIES, LP - Northfield
Hazard

Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.

Sold states
US Nationwide distribution in the states of CA, MN, NC, NY, OK, PA, TN, TX.
Affected count
800 kits
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
BAUSCH + LOMB BASIC OPHTHALMIC PACK, REF LYN023BSBLB. Convenience kit used in surgical procedures.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0157-2023

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