Medicel nanoPOINT Injector System Recalled for Potential Sterility Compromise
Medicel Ag is recalling one lot of nanoPOINT Injector Systems because damaged Tyvek lids may have compromised the sterile barrier.
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: The recall involves a risk-of-harm product (sterile barrier compromise) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Medicel Ag is recalling one lot (121402) of the nanoPOINT Injector System, item number 37-0000-08. The product is intended to fold and insert STAAR Surgical Collamer nanoFLEX or Afinity IOLs during a surgical procedure in a human eye. The recall involves 68 boxes, or 680 units, which were distributed nationwide.
The firm initiated this recall after noticing that the Tyvek lids on the injectors might have been damaged. This damage could negatively affect the stability of the sterile barrier, potentially compromising the sterility of the device. The source text does not report any specific illnesses or injuries associated with this recall.
Healthcare providers and patients should check their inventory for the specific lot number 121402. If the product is found, it should be removed from use and returned to the manufacturer or the appropriate regulatory authority as directed.
The recalled product
- Product
- Product Name: nanoPOINT Injector System, item number 37-0000-08. Intended to fold and insert a STAAR Surgical Collamer¿ nanoFLEX or Afinity IOLs, through surgical procedure in a human eye.
- Manufacturer
- Medicel Ag
- Hazard
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)
- Item number 37-0000-08 Lot number of the recalled products: LOT121402
Distribution
Distributed nationwide across the United States.
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