The Recall Desk
HighFDA (Devices)·Z-0155-2023·Announced 2022-11-09

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.

What this means for you

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
Hazard
  • seal-breach
  • sterility-compromise

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

Distributed nationwide across the United States.

Related recalls

Same category