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.
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: 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.
- 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
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.
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