Aaren Scientific Recalls Intraocular Lenses Due to Non-Compliant Instructions
Aaren Scientific is recalling 28 intraocular lenses because the instructions for use do not fully comply with US requirements.
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 and involves a documentation issue (non-compliant instructions for use) rather than a direct physical defect or reported injury, fitting the criteria for moderate severity.
Plain-English summary
Aaren Scientific, Incorporated is recalling 28 units of Intraocular Lenses (IOL), Part No. EC-3 PAL. The affected devices are indicated for primary implantation in the capsular bag of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed.
The recall was initiated because the instructions for use (IFU) for these devices are not fully compliant with US requirements. The agency has classified this as a Class II recall.
The affected units were distributed in the states of Oklahoma, Kansas, Florida, and Alabama. Consumers and healthcare providers should check their records for the specific serial numbers listed in the official recall notice to determine if they possess affected units.
The recalled product
- Product
- Intraocular Lens (IOL), Part No. EC-3 PAL, Diopter: 17.5, 18.0, 18.5, 19.0, 19.5, 21.5, 23.5, 9.0, 22.5, 23.0, 21.0, 24.0. The device is indicated for primary implantation in the capsular bag of the eye for the visual correction of aphakia in adult patients in whom a…
- Manufacturer
- Aaren Scientific, Incorporated
- Hazard
- Affected units
- 28
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 (20)
- Serial No. 1181331102
- 1181321102
- 1393231208
- 1117161211
- 1180941102
- 1031031102
- 1190261307
- 1190231307
- 1190091307
- 1190101307
- 1190431307
- 1190441307
- 1276591307
- 1305951307
- 119071307
- 1176951102
- 1192921102
- 1277111307
- 1189541307
- 1189551307
Distribution
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