Z-1227-2020Class II

Coopervision Vertex Toric /2 Clear Toric- Power -2.50 -0.75 /90 Soft (hydrophilic) Contact Lens (extended...

Name: Z-1227-2020 Coopervision Vertex Toric /2 Clear Toric- Power -2.50 -0.75 /90 Soft (hydrophilic) Contact Lens (extended...
Creator: CooperVision Inc.
Published: 2020-01-13
License: https://open.fda.gov/license/

CooperVision, Inc. / initiated 2020-01-13 / Terminated / root cause: manufacturing process

FDA source

CooperVision Inc. began a recall of Coopervision Vertex Toric /2 Clear Toric- Power -2.50 -0.75 /90 Soft (hydrophilic) Contact Lens (extended wear) on 2020-01-13. FDA classified it as Class II and gives the reason as "Incorrect power of lenses than the expected". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1227-2020
Classification: Class II
Status: Terminated
Initiated: 2020-01-13
Posted: 2020-01-27
Terminated: 2020-07-22
Recalling firm: CooperVision, Inc.
Product: Coopervision Vertex Toric /2 Clear Toric- Power -2.50 -0.75 /90 Soft (hydrophilic) Contact Lens (extended wear)
Product code: LPM Lenses, Soft Contact, Extended Wear
Reason for recall: Incorrect power of lenses than the expected
Root cause tag: manufacturing process
FDA root cause: Process control
Action: CooperVision issued Device Correction letter dated 1/20/19, stating reason for recall, health risk and action to take: Examine your inventory for the impacted lot numbers on the enclosed Ship Report. " Stop any further distribution of the specified lots of Vertex Toric and 2 Clear Toric lenses as appropriate. " Please discard product and contact CooperVision, Customer Service department at 1-800-340-2020 to receive credit and/or complimentary replacement product. Questions contact CooperVision Customer Service at 1-800-341-2020, 9:00 AM 7:00 PM ET, Monday Friday.
Quantity in commerce: 216 units
Distribution: US Nationwide Distribution
Product codes and lots: Lot Numbers: 15627000009010 15627050004010 16656000008010

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1227-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1227-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-13
Z-1228-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-13

Product code LPM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)