Surgical Eye Kit Pouches Recalled for Seal Defects
Medline recalls Bausch + Lomb Eye surgical kits due to breather pouches with openings in the seal. Affected kits were distributed to healthcare facilities nationwide; unopened kits should not be used.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall involving compromised seals on sterile surgical kits, presenting a risk of contamination to surgical materials. No illnesses or injuries have been reported; the hazard is preventive, fitting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling Bausch + Lomb Eye Pack surgical kits (Reference LYN003EYSPA, Lot 22DBM504) due to defects in the breather pouches. The company received complaints indicating that some breather pouches in the sterile surgical kits have openings in their seals.
A compromised seal on sterile surgical kit components risks allowing microbial contamination or other foreign material to enter the kit during storage or handling. This could potentially compromise the sterility of surgical instruments and materials intended for ophthalmic surgical procedures.
The affected kits were distributed nationwide in California, Minnesota, North Carolina, New York, Oklahoma, Pennsylvania, Tennessee, and Texas. A total of 95 kits are subject to this recall.
Users should discontinue use of affected kits immediately. Healthcare facilities and consumers in possession of the recalled product should contact Medline Industries for replacement or disposal instructions.
The recalled product
- Product
- BAUSCH + LOMB EYE PACK, REF LYN003EYSPA. Convenience kit used in surgical procedures.
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Surgical Kit
- Affected units
- 95
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- GTIN (01) 40195327061327
- Lot Number 22DBM504
Distribution
Part of a larger recall action
This product is one of 13 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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