FDA Medical Device Recalls (openFDA)
CooperVision Inc.: Coopervision Vertex Toric /2 Clear Toric- Power +2.25 -0.75/120 Soft (hydrophilic) Contact Lens (extended wear)
- Recall number
- Z-1228-2020
- Recalling firm
- CooperVision Inc.
- Product
- Coopervision Vertex Toric /2 Clear Toric- Power +2.25 -0.75/120 Soft (hydrophilic) Contact Lens (extended wear)
- Status
- Terminated
- Initiated
- 2020-01-13
- Posted
- 2020-01-27
- Terminated
- 2020-07-22
- Reason
- Incorrect power of lenses than the expected
- 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
- 24
- Distribution
- US Nationwide Distribution
- Lot, serial or model codes
- Lot Numbers: 15628000006509 15628000007509
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LPM
- Firm FEI
- 3005724763
- Firm city
- West Henrietta
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28