High FDA (Devices)·Z-1705-2022·Announced 2022-09-14

Eye Surgery Packs Recalled Due to Improper Sterilization Validation

American Contract Systems is recalling various eye and cataract surgery packs distributed to US health systems because the products were exposed to multiple sterilization cycles without validation. Unvalidated sterilization may compromise device sterility.

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: This is an FDA Class II medical device recall involving surgical packs where the sterilization process was not validated for multiple exposures, creating a risk of compromised sterility. No illnesses or injuries have been reported, meeting the criterion for High severity: a risk-of-harm product where injury has not yet been reported.

Plain-English summary

American Contract Systems, Inc. is recalling various eye packs and cataract surgery packs that were distributed to health systems and medical distributors across the United States. The recalled products include four specific lots with the following identifiers: Tray Number BLSE37K (Lot 820211), Tray Number MECA21P (Lot 786211), Tray Number CMEY17AD (Lot 760211), and Tray Number CXEY80X (Lot 749211).

The products are being recalled because they were exposed to multiple sterilization cycles without validation for multiple exposures. This means the sterilization process used was not validated to ensure the products remained sterile after repeated cycles, potentially compromising the sterility of the surgical device packs.

The affected products were distributed to health systems and medical device distributors in Arizona, Florida, Iowa, Illinois, Massachusetts, Minnesota, Missouri, Ohio, Nebraska, Pennsylvania, Rhode Island, South Dakota, and Texas.

Health systems and distributors who received these products should stop using them immediately and contact American Contract Systems, Inc. for instructions on return and replacement. Patients who may have received treatment using these packs should consult their healthcare provider.

The recalled product

Product: Various eye packs, cataract packs
Manufacturer: American Contract Systems, Inc.
Category: Medical Device — Surgical / Eye Surgery
Hazard: improper-sterilization
sterility-compromise
Affected units: 4

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 (16)

Tray Number
Sterilization Lot
Lot Number
Bag Serial Number 1) BLSE37K
2106292
820211
15017475-004 2) MECA21P
2108022
786211
44234851-005 3) CMEY17AD
2108301
760211
15101886-004 4) CXEY80X
2109083
749211
15109749-004

Distribution

Distributed in 13 states:

Part of a larger recall action

This product is one of 17 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 17 products in this recall →

Same manufacturer · American Contract Systems, Inc.

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