The Recall Desk
HighFDA (Devices)·Z-0158-2023·Announced 2022-11-09

Surgical Cataract Pack Recalled Due to Compromised Sterile Packaging

Medline Industries is recalling 300 units of Bausch + Lomb Cataract Packs due to breather pouches with seal openings that may compromise sterility. The affected surgical 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: FDA Class II medical device with compromised sterile packaging (seal openings in breather pouches) representing risk of contamination in surgical procedures, with no reported illnesses or injuries to date.

Plain-English summary

Medline Industries, LP is recalling the Bausch + Lomb Cataract Pack (REF VAL009CTSGA) due to complaints about breather pouches with openings in their seals. This cataract surgical kit is used as a convenience pack in surgical procedures and is affected by compromised seal integrity.

The recall affects 300 kits distributed nationwide in California, Minnesota, North Carolina, New York, Oklahoma, Pennsylvania, Tennessee, and Texas. The affected lot number is 22DBN862.

Healthcare facilities in the affected states that have received these kits should discontinue use and contact Medline Industries for replacement or handling instructions.

The recalled product

Product
BAUSCH + LOMB CATARACT PACK, REF VAL009CTSGA. Convenience kit used in surgical procedures.
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical / Cataract Kit
Hazard
  • sterility-breach
  • contamination-risk

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) 40193489577540
  • Lot Number 22DBN862

Distribution

Distributed nationwide across the United States.

Related recalls

Same category