Agency classClass IIOur severity:High FDA (Devices)·Z-0832-2024·Announced 2024-02-07

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.

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: 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.
Category: Medical Device — Surgical Kits / Ophthalmic
Hazard: device-failure
drug-efficacy-loss
sterilization-residue
Affected units: 940

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.

Part of a larger recall action

This product is one of 18 recalled by American Contract Systems, 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 18 products in this recall →

Same manufacturer · American Contract Systems, Inc.

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