Reported Aug 9, 2023 · Ongoing
TECNIS Eyhance IOL, REF: ICB00, STERILE.EO, Rx Only
Johnson & Johnson Surgical Vision, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Johnson & Johnson Surgical Vision, Inc. · 31 Technology Dr Ste 200 · Irvine, CA · 92618-2302
Is this the product you have?
- TECNIS Eyhance IOL
- REFICB00, STERILE.EO, Rx Only
- Lot codes and dates
- UDI-DIN/A/
- Serial Numbers
61 of 61 codes
804664223680466522368046662236804667223680466822368046692236804670223680467122368046722236804673223680467422368046752236804676223680467722368046782236804679223680468022368046812236804682223680468322368046842236804685223680468622368046872236804688223680468922368046902236804691223680469222368046932236804694223680469522368046962236804697223680469822368046992236804700223680470122368047022236804703223680470422368047052236804706223680470722368047082236804710223680471122368047122236804713223680471422368047152236804716223680471722368047182236804719223680472022368047212236804722223680472322368047242236
- Amount recalled
- 61 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Why it was recalled
Their is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fiducial marks.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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