The Recall Desk
HighFDA (Devices)·Z-2270-2024·Announced 2024-07-17

24K Premium Contact Lenses Recalled Due to Potential Bacterial Contamination

Ontact Inc. is recalling 24K Premium contact lenses distributed in California and Nevada due to potential bacterial contamination.

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 medical device where injury has not yet been reported. Bacterial contamination of contact lenses poses a meaningful risk of infection, and the FDA's Class II classification confirms the agency's concern, but the absence of reported illnesses or injuries means this does not meet the threshold for Severe (4) or Critical (5).

Plain-English summary

Ontact Inc. is recalling 24K Premium contact lenses due to potential bacterial contamination. The recalled product was distributed nationwide in California and Nevada, affecting approximately 2,842 units.

Contact lenses are medical devices that come into direct contact with the eye. Bacterial contamination of these lenses poses a risk of infection. The FDA classified this recall as Class II based on the potential health risk.

The recalled product

Product
24K Premium Lense, Distributed by Updream Inc.
Manufacturer
Ontact Inc
Hazard
  • bacterial-contamination
  • infection-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 (1)

  • All distributed lenses.

Distribution

Distributed nationwide across the United States.