Insight Instruments Recalls M.I.S. Ophthalmic Cannulas Due to Misclassification
Insight Instruments is recalling 776 M.I.S. Ophthalmic Cannulas distributed in Indiana and Illinois because the device was misclassified.
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 due to a misclassification of the device, which is a documentation or regulatory issue rather than a direct physical hazard. This aligns with the rubric for minor labeling or documentation issues.
Plain-English summary
Insight Instruments, Inc. is recalling 776 units of the M.I.S. (Multi-Port Illumination System) Ophthalmic Cannula. The recall was initiated due to a misclassification of the medical device.
The affected units were distributed in Indiana and Illinois. The specific lot numbers involved in this recall are M53157, M55115, M56929, M58551, and M61862.
The source text does not provide specific instructions for consumers or healthcare providers regarding the next steps for these devices.
The recalled product
- Product
- Insight Instruments MIS ( Multi-Port Illumination System) Illuminated pilot tubes work like a ceiling light while simultaneously protecting the entry sites. Illumination automatically follows the movement of the two surgical instruments inserted into the M.I.S. cannulas.…
- Manufacturer
- Insight Instruments, Inc.
- Category
- Medical Device — Ophthalmic
- Hazard
- Affected units
- 776
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 (5)
- Lot Numbers: M53157
- M55115
- M56929
- M58551
- M61862.
Distribution
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