Ophthalmic procedural kits recalled due to inadequate sterilization validation
American Contract Systems is recalling 940 ophthalmic surgical kits nationwide due to undocumented components that may lack functionality, drug efficacy, or contain elevated sterilization residuals.
What this means for you
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: FDA Class II recall with no reported illnesses or injuries. The potential harms—loss of functionality and drug efficacy—are theoretical. Per the rubric, risk-of-harm products where injury has not yet been reported are scored as High (3).
Plain-English summary
American Contract Systems, Inc. is recalling 940 units of custom procedural convenience kits and trays for ophthalmic use. The recalled products include EYE PACK kits (model LVEY27) and Laminectomy kits (model UIOL34AG), distributed nationwide across the United States.
During an internal investigation, the company discovered that certain components were added to the sterilization trays without documentation confirming they could safely withstand elevated temperatures and the sterilization process. As a result, these components may experience loss or lack of functionality, loss of drug efficacy (if applicable), and may contain higher than specified ethylene oxide (EO) sterilization residuals.
Healthcare facilities and clinicians using these kits should discontinue use of affected lot numbers and contact American Contract Systems for instructions on returns or replacements. The FDA has classified this as a Class II recall. A complete list of affected lot numbers and expiration dates is available in the FDA's official recall notice.
The recalled product
- Product
- Custom procedural convenience kits and trays, Ophthalmic use, labeled as: a) EYE PACK, kit number LVEY27; b) Laminectomy, kit number UIOL34AG
- Manufacturer
- American Contract Systems, Inc.
- Hazard
- device-failure
- drug-efficacy-loss
- sterilization-residue
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 (18)
- a) LVEY27
- UDI/DI 00191072135728
- Lot Numbers: 840221
- exp. 6/29/2023
- 771221
- exp. 8/17/2023
- 715221
- exp. 10/12/2023
- 982231
- exp. 1/18/2024
- 917231
- exp. 3/24/2023
- b) UIOL34AG
- UDI/DI 00191072191168
- Lot Numbers: 912231
- exp. 3/29/2024
- 898231
- exp. 4/12/2024
Distribution
Distributed nationwide across the United States.
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