Biofinity XR Toric 6-pack- Soft (hydrophilic) Contact Lens (extended wear)
Summary
The FDA issued a Class II for Biofinity XR Toric 6-pack- Soft (hydrophilic) Contact Lens (extended wear) by CooperVision, Inc.. Reason: Manufactured with misaligned axis resulting in lenses with the incorrect power, users may experience poor visual acuity.
Details
Source
Device Recall
External ID
Z-1197-2023
Action Date
2023-03-08
Status
Ongoing
Category
device
Product Description
Biofinity XR Toric 6-pack- Soft (hydrophilic) Contact Lens (extended wear)
Lot/Code Info: UDI: N/A Lot Numbers: R24377024, R24377026, R24381716, R24416900
Quantity Affected: 24 units
Reason for Recall
Manufactured with misaligned axis resulting in lenses with the incorrect power, users may experience poor visual acuity
Distribution
US Nationwide distribution in the states of CA, OH, NC, PA.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-01-26
Company
West Henrietta, NY
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 149 device recalls issued in the same week, part of 403 device-related FDA actions this month.
CooperVision, Inc. has 27 FDA actions in our database, including 24 recalls and 3 clearances.
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 (CooperVision, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does CooperVision, Inc. have FDA actions?
CooperVision, Inc. has 27 FDA actions in our database, including 24 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1197-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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