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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 83,542
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
Part of a larger recall action
This product is one of 2 recalled by PARAGON VISION SCIENCES, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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