FDA-Device2024-01-24Class II
TECNIS Toric II OptiBlue IOL Models ZCW
Johnson & Johnson Surgical Vision, Inc.
Hazard
Due to intraocular lens containing an angle out of specification (OOS). The cylinder axis marks do not meet product specifications for the allowable angle between Low Power Meridian (LPM) and toric cylinder axis marks.
Sold states
International distribution to the country of Japan.
Affected count
36
Manufactured in
31 Technology Dr Ste 200, N/A, Irvine, CA, United States
Products
TECNIS Toric II OptiBlue IOL Models ZCW
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0735-2024Don't want to check this manually?
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