05/15/2025
ATTN: NUTRIFILL USERS (FOR SCLERAL AND HYBRID LENSES).
Please note there is a voluntary recall by Contamac Solutions, Inc on some lots of their product Nutrifill. Please read below for details.
May 15, 2025
Contamac Solutions, Inc. is voluntarily recalling lots HFH, HGC, HGI, HGN, HKF, HKK of Nutrifill, a preservative free contact lens insertion solution because products may not be sterile.
Serious injuries may have or could occur due to non-sterile products. From seven complaints, we have received reports of twenty-three serious injuries that the recalled product may have contributed to; injuries ranging from redness, burning, and irritation to infections that sometimes resulted in the development of corneal ulcers have been reported. Please review the information in this notification and follow the instructions provided. The recall is being made with the knowledge of the United States Food and Drug Administration.
Reason For the Voluntary Recall:
Through the investigation of complaints from 7 different sources, two significant quality failures at our contract manufacturer were identified as the likely cause of non-sterile products. During investigative sterility testing conducted by both the contract manufacturer and Contamac Solutions, samples from lots HFH, HGI, HGN, and HKK were found to be non-sterile.
In total, 605,465 ampoules manufactured within these affected lots may be non-sterile. We have halted distribution to ensure the safety of our products while corrective and preventative actions are implemented at the contact manufacturer’s facility.
Risk to Health:
A non-sterile solution with potential bacterial contamination can cause infections that may lead to vision loss if untreated. Individuals who have recently undergone eye surgery, have an active external ocular disease, or have a condition affecting the integrity of the eye are at higher risk of complications from using a non-sterile product.
The potential hazards range from conjunctivitis (significant adverse event) to an infectious corneal ulcer (serious adverse event). If not managed appropriately (i.e. medical intervention), the spread of the infection can progress to the point of severe corneal scarring and loss of vision. In some cases, a corneal transplant becomes necessary to restore vision.
Actions Taken by the Distributor:
If you are in possession of Nutrifill products, please take the following steps:
1. Refer to the package label and Product Distribution Information below to verify the product that is impacted.
2. Immediately quarantine and discontinue sales of the impacted product. Return any undistributed product by contacting recall@contamacsolutions.com to initiate a return and refund.
3. Provide the recall notification to all those who need to be aware, including others within your organization or to any organization where the affected devices have been transferred. If you have further distributed the product, please provide this recall notification to those distributors and ask them to provide a copy to their customer. A copy of the Recall Public Notice can be by visiting contamacsolutions.com or by clicking here.
4. Notify us using the following link to confirm that you received this recall notification, contacted customers potentially affected by this recall, and returned the impacted product:
Distributor Response Form: please reach out to recall@contamacsolutions.com for assistance.
Product Lot Number Identification:
The number can be found on a sticker affixed to the side of the box below the contact information or embossed on the front of the ampoule below the Nutrifill logo.
Product Distribution Information:
Product Name: Nutrifill
Unique Device Identifier (UDI): 00850012123002
Lot Number: HFH
Distribution Dates: June 13, 2024 to July 9, 2024
Expiration Date : 02/28/2026
Quantity: 104,370 ampoules
Product Distribution Information:
Product Name: Nutrifill
Unique Device Identifier (UDI): 00850012123002
Lot Number: HGC
Distribution Dates: July 9, 2024 to July 24, 2024
Expiration Date : 03/31/2026
Quantity: 104,895 ampoules
Product Distribution Information:
Product Name: Nutrifill
Unique Device Identifier (UDI): 00850012123002
Lot Number: HGN
Distribution Dates: July 24, 2024 to August 22, 2024
Expiration Date : 03/31/2026
Quantity: 107,450 ampoules
Product Distribution Information:
Product Name: Nutrifill
Unique Device Identifier (UDI): 00850012123002
Lot Number: HGI
Distribution Dates: August 22, 2024 to September 10, 2024
Expiration Date : 03/31/2026
Quantity: 105,595 ampoules
Product Distribution Information:
Product Name: Nutrifill
Unique Device Identifier (UDI): 00850012123002
Lot Number: HKF
Distribution Dates: September 10, 2024 to September 27, 2024
Expiration Date : 07/31/2026
Quantity: 81,270 ampoules
Product Distribution Information:
Product Name: Nutrifill
Unique Device Identifier (UDI): 00850012123002
Lot Number: HKK
Distribution Dates: September 27, 2024 to October 18, 2024
Expiration Date 07/31/2026
Quantity: 100,975 ampoules
