The Recall Desk
HighFDA (Devices)·Z-2515-2023·Announced 2023-09-13

ISee Ortho-K Contact Lenses Recalled Due to Lack of FDA Approval

Paragon Vision Sciences is recalling 83,542 ISee Ortho-K lenses because the manufactured product lacks FDA approval coverage. This is a Class II recall.

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: Contact lenses are risk-of-harm medical devices. This Class II recall addresses regulatory non-compliance—manufactured lenses are not covered by existing FDA approval—with no reported illnesses or injuries. Per the severity rubric, risk-of-harm products without reported harm score as High (3).

Plain-English summary

Paragon Vision Sciences, Inc. is recalling approximately 83,542 ISee Ortho-K contact lenses because the manufactured lenses are not covered by existing FDA approval. This is a Class II recall issued by the FDA.

The affected product includes all lots bearing product code DI-B22208. The lenses were distributed worldwide, including throughout the United States (all 50 states, Washington DC, and Puerto Rico) and internationally to Australia, Canada, China, Japan, and Vietnam.

The recalled product

Product
ISee Ortho-K Lens
Manufacturer
PARAGON VISION SCIENCES, Inc
Category
Medical Device — Ophthalmic - Contact Lenses
Hazard
  • regulatory-non-compliance
  • unapproved-device

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)

  • All Lots
  • DI-B22208

Distribution

Distributed nationwide across the United States.

Related recalls

Same category