Aaren Scientific AERO IOL Injection System Recalled for Incorrect Storage Labeling
Aaren Scientific Inc. is recalling 786 boxes of AERO IOL Injection Systems because the recommended storage temperature on the label is incorrect.
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 explicitly states the issue is an incorrect storage temperature on the label and does not report any illnesses or injuries. Per the rubric, minor labeling errors without reported harm fall under Moderate severity.
Plain-English summary
Aaren Scientific Inc. is recalling 786 boxes of the AERO IOL Injection System, Part #003500-0025-282. The product is a sterile, prescription device used to fold and insert intraocular lenses (IOLs). The recall is due to an error in the recommended storage temperature listed on the product label.
The affected units were distributed nationwide, including Puerto Rico. The recall covers specific lot numbers with expiration dates ranging from January 31, 2018, to December 31, 2018. The source text does not report any illnesses, injuries, or adverse events associated with this labeling error.
Healthcare providers and consumers should stop using the affected AERO IOL Injection Systems and contact Aaren Scientific Inc. for further instructions or a return. The recall is classified as Class II by the FDA, indicating a situation where use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- AERO IOL Injection System containing 10 Z28 Cartridges per box, Part #003500-0025-282, Sterile, Rx. The firm name on the label is Aaren Scientific Inc., Ontario, CA. Used to fold and insert the firm's IOL's.
- Manufacturer
- Aaren Scientific Inc.
- Category
- Medical Device — Ophthalmic
- Hazard
- Affected units
- 786
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 (12)
- Lot numbers and expiration dates: 160204
- 1/31/2018
- 160505
- 4/30/2018
- 161006
- 9/30/2018
- 161018
- 161028
- 161219
- 11/30/2018
- and 170120
- 12/31/2018.
Distribution
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