The Recall Desk
HighFDA (Devices)·Z-0160-2023·Announced 2022-11-09

Surgical Cataract Kits Recalled for Defective Breather Pouch Seals

Medline has recalled Bausch + Lomb cataract surgical kits due to breather pouches with seal openings that could compromise sterility. Affected kits were distributed nationwide.

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 risk-of-harm product where the hazard—compromised sterile barrier in surgical instruments—is real but no illness or injury has been reported. The defect presents a theoretical risk of surgical site contamination without documented clinical consequences.

Plain-English summary

Medline Industries has recalled Bausch + Lomb Cataract Tray kits (Reference LYN023FACTB) due to breather pouches with openings in the seal. The defect could compromise the sterility of the surgical instruments contained within the kit.

The recall affects 28 kits distributed nationwide across California, Minnesota, North Carolina, New York, Oklahoma, Pennsylvania, Tennessee, and Texas. Affected kits are identified by Lot Number 22DBM506.

Healthcare providers should discontinue use of affected kits immediately and contact Medline for further guidance.

The recalled product

Product
BAUSCH + LOMB CATARACT TRAY, REF LYN023FACTB. Convenience kit used in surgical procedures.
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Kits
Hazard
  • seal-defect
  • sterile-barrier-failure

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) 10889942339730
  • Lot Number 22DBM506

Distribution

Distributed nationwide across the United States.

Related recalls

Same category