FDA Medical Device Recalls (openFDA)
CooperVision, Inc.: Brand Name: Pearle Vision 1 day Product Name: (somofilcon A) Contact Lens Model/Catalog Number: Pearle Vision 1 day
- Recall number
- Z-3248-2026
- Recalling firm
- CooperVision, Inc.
- Product
- Brand Name: Pearle Vision 1 day Product Name: (somofilcon A) Contact Lens Model/Catalog Number: Pearle Vision 1 day
- Status
- Open, Classified
- Initiated
- 2026-08-12
- Posted
- 2026-09-18
- Terminated
- not on file
- Reason
- A small number of lenses within the affected lot are of the incorrect power.
- Root cause
- Process control
- Action
- On August 24, 2026 URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. Actions to be taken: 1. Please stop any further distribution of products from the designated lot number. 2. Dispose of the affected product in your inventory or that is returned to you. 3. Within the next five (5) business days, please complete the response form provided and return it. If you have no lenses from these specified lots, please put 0 in Quantity and return the form. 4. We recommend authorized distributors contact your accounts, and Eye Care Practitioners contact your patients who have received the affected product, with the enclosed Customer Communication Letter . 5. Please instruct any patients to return any affected product to their Eye Care Practitioner or purchase location for replacement or credit.
- Quantity
- 3060
- Distribution
- US Nationwide distribution in the states of MN, OH, WI.
- Lot, serial or model codes
- Pearle Vision 1 day; Carton Lot # 11727620152030; Blister Lot # CB132348;
- 510(k) numbers
- ["K130331"]
- PMA numbers
- not on file
- Product code
- MVN
- 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