FDA-Device2023-08-09Class II
TECNIS Eyhance IOL, REF: ICB00, STERILE.EO, Rx Only
Johnson & Johnson Surgical Vision, Inc.
Hazard
Their is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fiducial marks.
Sold states
International distribution to the countries of China, India, Korea.
Affected count
61 units
Manufactured in
31 Technology Dr Ste 200, N/A, Irvine, CA, United States
Products
TECNIS Eyhance IOL, REF: ICB00, STERILE.EO, Rx Only
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2289-2023Don't want to check this manually?
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