FDA Recalls DeRoyal BASIC EYE PACK Medical Device Kits
The FDA has issued a recall of 50 kits of DeRoyal BASIC EYE PACK, a medical device distributed across 23 U.S. states. The specific reason for the recall is not provided in available source information.
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: Medical device recall classified as FDA Class II involving a product that contacts the eye (risk-of-harm category). No injuries or illnesses have been reported. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High severity.
Plain-English summary
DeRoyal Industries Inc has initiated a voluntary recall of the DeRoyal BASIC EYE PACK (Reference 89-8337.09), a medical device, affecting 50 kits. The product was distributed across 23 U.S. states: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, and Mississippi.
The manufacturer initiated this recall on November 3, 2022, through multiple notification methods including email, fax, letter, press release, telephone, and direct firm visits. The recall involves five lot numbers with varying expiration dates: Lot 57118632 (exp. 9/1/2024), Lot 57184285 (exp. 12/1/2024), Lot 57630628 (exp. 4/1/2025), Lot 57745978 (exp. 4/1/2025), and Lot 57688413 (exp. 12/1/2024).
The FDA has classified this as a Class II recall. The specific hazard or defect prompting the recall is not stated in available source information. Consumers in possession of affected lot numbers should not use the product. For further information, contact DeRoyal Industries Inc or consult the FDA's official recall notice.
The recalled product
- Product
- DeRoyal BASIC EYE PACK, REF 89-8337.09
- Manufacturer
- DeRoyal Industries Inc
- Hazard
- eye-injury-risk
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 (4)
- Lot Numbers: Lot 57118632 exp 9/1/2024
- Lot 57184285 exp 12/1/2024
- Lot 57630628 exp 4/1/2025
- Lot 57745978 exp 4/1/2025: Lot 57688413 exp 12/01/2024
Distribution
Distribution scope not specified by the agency.
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