Johnson & Johnson Surgical Vision, Inc. recalls TECNIS Toric II OptiBlue IOL Models ZCW
- Recall date
- December 12, 2023
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0735-2024
- FDA classification
- Class II
- Brand / firm
- Johnson & Johnson Surgical Vision, Inc.
- Sold / distributed
- International distribution to the country of Japan.
Why it was recalled
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
TECNIS Toric II OptiBlue IOL Models ZCW
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