AcuFocus Recalls KAMRA Corneal Inlays Due to Shelf Life Labeling Concerns
AcuFocus is recalling 182 KAMRA ACI 7000 Corneal Inlays because of concerns regarding the labeled shelf life. The devices were distributed in Canada, Germany, Saudi Arabia, Turkey, and the United Kingdom.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text identifies the issue as a labeling concern regarding shelf life without reporting any illnesses, injuries, or hospitalizations. This aligns with the rubric for moderate severity involving labeling errors or precautionary measures.
Plain-English summary
AcuFocus, Inc. is recalling 182 units of KAMRA ACI 7000 Corneal Inlays, Part No. 76195-01 and 76195-10. The recall is being conducted due to concerns with the labeled shelf life of the devices. The affected lots are A534-1014 and A535-1014.
The KAMRA inlay is indicated for the improvement of near visual acuity in one eye of a presbyopic patient. The recalled units were distributed internationally in Canada, Germany, Saudi Arabia, Turkey, and the United Kingdom.
Consumers and healthcare providers should stop using the affected devices and contact AcuFocus for further instructions.
The recalled product
- Product
- KAMRA Inlay, ACI 7000 Corneal Inlay, Part No. 76195-01 and 76195-10 (OUS) Labeling: The KAMRA inlay is indicated for the improvement of near visual acuity in one eye (usually the non-dominant eye) of a presbyopic patient.
- Manufacturer
- AcuFocus, Inc.
- Category
- Medical Device — Ophthalmic
- Hazard
- Affected units
- 182
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)
- Lots A534-1014 and A535-1014
Distribution
Distribution scope not specified by the agency.
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