FDA Medical Device Recalls (openFDA)
Clerio Vision: EXTREME H2O 59% (hioxifilcon A) spherical soft contact lens for daily wear - Product Usage: 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-1352-2021
- Recalling firm
- Clerio Vision
- Product
- EXTREME H2O 59% (hioxifilcon A) spherical soft contact lens for daily wear - Product Usage: 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
- 2021-02-16
- Posted
- not on file
- Terminated
- 2023-07-05
- Reason
- Contact lenses may be mislabeled with the incorrect lens power.
- Root cause
- Process control
- Action
- Customers were contacted by phone on 02/16/2021 and instructed to segregate and return product with the affected lot number. An URGENT MEDICAL DEVICE RECALL were sent to impacted customers by standard USPS first class mail beginning on 03/03/2021. Customers are instructed to examine their inventory, cease all distribution and quarantine affected product, and complete and return by email the response form included with the recall notice. Customers are to return any affected inventory via US Mail, marking the package, Attention: Returns Department Recall Product. The letter instructs customers identify and notify any customers the affected product was further distributed to.
- Quantity
- 153 lenses
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of Illinois and Missouri, and the countries of Denmark, Germany, The Netherlands, Switzerland.
- Lot, serial or model codes
- Lot Number: 0114511565, UPC Code: 675506700657 (6 pack), 675506668650 (individual)
- 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