CLARITI 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact Lens with UV blocker
Summary
The FDA issued a Class II for CLARITI 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact Lens wit by CooperVision Inc.. Reason: Misaligned placement of an axis mark can cause the patient to experience blurred vision.
Details
Source
Device Recall
External ID
Z-2146-2021
Action Date
2021-08-04
Status
Terminated
Category
device
Product Description
CLARITI 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact Lens with UV blocker
Lot/Code Info: Lot Number: U0108833
Quantity Affected: 90 lenses
Reason for Recall
Misaligned placement of an axis mark can cause the patient to experience blurred vision
Distribution
Worldwide distribution - US Nationwide distribution in the states of FL, NY, TN, OH, NC, WI and the countries of France, United Arab Emirates, Brazil, Australia, New Zealand, Taiwan, Canada.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-05-19
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 173 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-2146-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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