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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device
Medical Devices/Surgical Equipment

Synergetics Inc: I-PACK Injection Kits Recalled for Potential Sterilization Certificate Issues

Agency Publication Date: July 11, 2024
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Summary

Synergetics Inc. is recalling 167 BAUSCH+LOMB I-PACK Injection Kits, which are used for administering injections into the eye. The recall was initiated because sterilization certificates from the supplier could not be validated, meaning the sterility of these medical kits cannot be guaranteed. These products were distributed nationwide across the United States. Consumers should stop using affected kits and contact their healthcare provider or the manufacturer for further instructions regarding a potential refund.

Risk

If the sterilization of these eye injection kits cannot be confirmed, there is a critical risk that the tools could be contaminated with bacteria or other pathogens. This poses a serious risk of eye infections or other complications for patients receiving intravitreal injections.

What You Should Do

  1. Check your medical supplies for BAUSCH+LOMB I-PACK Injection Kits with the following identifiers: REF 18060 (Lot P62764979R, UDI 20841305107544), REF 18061 (Lot P63044983R, UDI 20841305107551), REF 18069 (Lot P62764965R, UDI 20841305107605), or REF 18069W (Lot P62764970R, UDI 20841305107612).
  2. Immediately stop using any injection kits from the affected lots listed above.
  3. Contact Synergetics Inc. at their O Fallon, Missouri headquarters or your healthcare provider to discuss next steps, return procedures, and potential refunds.
  4. If you have experienced any adverse health effects or eye infections following the use of these kits, contact your doctor immediately.
  5. For further information or questions regarding this recall, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Contact healthcare provider or manufacturer for instructions.

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: BAUSCH+LOMB, I-PACK Injection Kit, REF 18060
Model / REF:
18060
Z-2251-2024
20841305107544
Lot Numbers:
P62764979R
Product: BAUSCH+LOMB, I-PACK Injection Kit with Drape, REF 18061
Model / REF:
18061
Z-2252-2024
20841305107551
Lot Numbers:
P63044983R
Product: BAUSCH+LOMB, I-PACK Injection Kit Custom, REF 18069
Model / REF:
18069
Z-2253-2024
20841305107605
Lot Numbers:
P62764965R
Product: BAUSCH+LOMB, I-PACK Injection Kit with Wire Speculum, REF 18069W
Model / REF:
18069W
Z-2254-2024
20841305107612
Lot Numbers:
P62764970R

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94793
Status: Active
Manufacturer: Synergetics Inc
Manufactured In: United States
Units Affected: 4 products (14 units; 2 units; 116 units; 35 units)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.