Reported Jan 24, 2024 · Ongoing
TECNIS Toric II OptiBlue IOL Models ZCW
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 Toric II OptiBlue IOL Models ZCW
- Lot codes and dates
- Model NumbersZCW375
- UDI codeN/A (not distributed in the U.S.)
- Serial Numbers
347390210734739121073473922107347393210734739421073473952107347396210734739721073474002107347401210734740221073474072107347408210734740921073474102107347411210734741221073474132107347415210734741621073474172107347418210734741921073474202107347422210734742321073474242107347425210734742621073474282107347429210734743121073474322107347433210734743421073474352107
- Amount recalled
- 36
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.
This product could cause temporary or reversible health problems — stop using it.
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