FDA Medical Device Recalls (openFDA)
Clerio Vision: Clerio Vision, extreme H2O monthly, MED, DIA 14.0 PWR -2.25, UPC 675506803334 (6 count) and UPC 675506804478 (12 count) - Product Usage: for daily wear is indicated for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit astigmatism of 0.75 Diopters or less that does not interfere with visual acuity.
- Recall number
- Z-0808-2021
- Recalling firm
- Clerio Vision
- Product
- Clerio Vision, extreme H2O monthly, MED, DIA 14.0 PWR -2.25, UPC 675506803334 (6 count) and UPC 675506804478 (12 count) - Product Usage: for daily wear is indicated for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit astigmatism of 0.75 Diopters or less that does not interfere with visual acuity.
- Status
- Terminated
- Initiated
- 2020-12-10
- Posted
- not on file
- Terminated
- 2023-07-05
- Reason
- One lot of contact lenses labeled as BC MED, DIA 14.0 PWR -2.25 contained BC MED, DIA 14.0, PWR -3.75 contact lenses
- Root cause
- Process control
- Action
- The firm initiated the recall by letter and email on 12/10/2020. The letter requested the following actions to be taken by the customer: "Distributors: Please immediately examine your inventory, cease all distribution and quarantine this product. Please complete the response form at the end of this notice and return by email to sarasotacustomercare@cleriovision.com even if you no longer have any of the product. Return any inventory via US Mail, marking the package, Attention: Returns Department Recall Product. Your account will be reimbursed for the returned goods and shipping cost. If you have further distributed this product, please identify your customers and notify them at once of this product recall. You may include this letter in your notification, or you can provide us with your customer list and we will notify them. Physicians/Opticians/Retailers: Please complete the response form at the end of this notice and return by email to sarasotacustomercare@cleriovision.com even if you no longer have any of the product. Return any inventory via US Mail, marking the package, Attention: Returns Department Recall Product. Your account will be reimbursed for the returned goods and shipping cost. If you have dispensed this product, please identify your patients/customers and notify them at once of this product recall. You may include this letter in your notification."
- Quantity
- 208 lenses
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- LOT 3100246509, EXP 2026/09
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LPL
- Firm FEI
- 3005184723
- Firm city
- Sarasota
- Firm state
- FL
- 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