Summary
The FDA issued a Class II for TECNIS Toric II OptiBlue IOL Models ZCW by Johnson & Johnson Surgical Vision, Inc.. Reason: Due to intraocular lens containing an angle out of specification (OOS). The cylinder axis marks do not meet product specifications for the allowable .
Details
Source
Device Recall
External ID
Z-0735-2024
Action Date
2024-01-24
Status
Ongoing
Category
device
Product Description
TECNIS Toric II OptiBlue IOL Models ZCW
Lot/Code Info: Model Numbers: ZCW375 UDI code: N/A (not distributed in the U.S.) Serial Numbers: 3473902107 3473912107 3473922107 3473932107 3473942107 3473952107 3473962107 3473972107 3474002107 3474012107 3474022107 3474072107 3474082107 3474092107 3474102107 3474112107 3474122107 3474132107 3474152107 3474162107 3474172107 3474182107 3474192107 3474202107 3474222107 3474232107 3474242107 3474252107 3474262107 3474282107 3474292107 3474312107 3474322107 3474332107 3474342107 3474352107
Quantity Affected: 36
Reason for Recall
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.
Distribution
International distribution to the country of Japan.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-12-12
Company
Irvine, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 203 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Johnson & Johnson Surgical Vision, Inc. has 13 FDA actions in our database, including 12 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Johnson & Johnson Surgical Vision, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Johnson & Johnson Surgical Vision, Inc. have FDA actions?
Johnson & Johnson Surgical Vision, Inc. has 13 FDA actions in our database, including 12 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0735-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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