Intravitreal Injection Kit Recalled for Unvalidated Sterilization Certificates
Synergetics Inc is recalling 35 units of the BAUSCH+LOMB I-PACK Intravitreal Injection Kit because sterilization certificates could not be validated, creating an 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 a Class I FDA recall, which per the rules never goes below score 4. No illnesses or injuries have been reported, but the hazard—unvalidated sterilization of eye-surgery devices—poses significant infection risk.
Plain-English summary
The FDA has issued a Class I recall for the BAUSCH+LOMB I-PACK Injection Kit with Wire Speculum (REF 18069W), manufactured by Synergetics Inc. This device is used for intravitreal injections in eye surgery. The recall affects 35 units distributed nationwide in the United States.
The recall was initiated because the supplier could not validate sterilization certificates for the affected devices. This means the sterilization status of these injection kits cannot be confirmed. Devices used in intravitreal injections must be sterile to prevent eye infections and other serious complications.
Patients who have received intravitreal injections with affected devices should consult their eye care provider. Consumers in possession of this device should discontinue use and contact the manufacturer or their healthcare provider for instructions on return or replacement.
The recalled product
- Product
- BAUSCH+LOMB, I-PACK Injection Kit with Wire Speculum, REF 18069W, for the administration of intravitreal injection (eye)
- Manufacturer
- Synergetics Inc
- Affected units
- 35
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 20841305107612
- Lot Number P62764970R
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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