The Recall Desk
HighFDA (Devices)·Z-0250-2022·Announced 2021-11-24

REGARD Basic Cataract Tray Recalled for Out-of-Specification Component

ROi CPS LLC is recalling 126 REGARD Basic Cataract trays because a Povidone-Iodine swabstick component is out of specifications. Affected trays were distributed in Florida, Louisiana, and Missouri.

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 an FDA Class II medical device recall involving an out-of-specification component. Without reported illnesses or injuries, the hazard remains theoretical. Per the severity rubric, risk-of-harm products without documented injury are classified as High.

Plain-English summary

ROi CPS LLC is recalling the REGARD Basic Cataract tray due to a quality issue with a critical component. The Povidone-Iodine swabstick manufactured by PDI, Inc. and incorporated into the cataract trays does not meet specifications.

Approximately 126 trays were distributed across Florida, Louisiana, and Missouri. The affected trays are identified by the following lot numbers: 88797G, 88392G, 87844G, 86422G, and 83645F.

The source does not report any illnesses or injuries related to this issue. Healthcare providers and facilities who received these trays should check their inventory against the affected lot numbers. If affected trays are identified, discontinue use and contact ROi CPS LLC for return or replacement instructions.

The recalled product

Product
REGARD Basic Cataract tray
Manufacturer
ROi CPS LLC
Category
Medical Device — Surgical / Ophthalmic Supplies
Hazard
  • quality-defect
  • component-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 (4)

  • Lots numbers: 88797G
  • 88392G
  • 87844G
  • 86422G and 83645F

Distribution

Distributed nationwide across the United States.

Related recalls

Same category