FDA-Device2023-08-09Class II

TECNIS Symfony, Extended Range of Vision IOL, REF: ZXR00, 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
42
Manufactured in
31 Technology Dr Ste 200, N/A, Irvine, CA, United States
Products
TECNIS Symfony, Extended Range of Vision IOL, REF: ZXR00, STERILE.EO, Rx Only

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2288-2023

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