Bausch+Lomb I-PACK Injection Kit Recalled for Unvalidated Sterilization
Synergetics Inc is recalling the Bausch+Lomb I-PACK Injection Kit nationwide because sterilization certificates could not be validated by the supplier. The unvalidated sterilization of this eye injection device poses a potential infection risk.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall. FDA Class I classification mandates a minimum severity score of 4. While no illnesses have been reported, unvalidated sterilization of invasive eye injection equipment creates a serious risk of infection.
Plain-English summary
Synergetics Inc is recalling the Bausch+Lomb I-PACK Injection Kit (REF 18060, Lot P62764979R) nationwide. This medical device is used for administering intravitreal injections—injections delivered directly into the eye. The recall affects 14 units.
The company initiated the recall because sterilization certificates provided by the supplier could not be validated. When sterilization cannot be confirmed for injection equipment, there is a risk of infection.
Patients who received intravitreal injections using this product and healthcare providers should be aware of this recall.
The recalled product
- Product
- BAUSCH+LOMB, I-PACK Injection Kit, REF 18060, for the administration of intravitreal injection (eye)
- Manufacturer
- Synergetics Inc
- Affected units
- 14
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 (2)
- UDI/DI 20841305107544
- Lot Number P62764979R
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Synergetics Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
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