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.
FDA Recall Z-1352-2021 · Posted None
Recalling FirmClerio Vision
Recall StatusTerminated
Product CodeLPL
Date Initiated2021-02-16
Date Terminated2023-07-05
Product Quantity153 lenses
Reason for Recall
Contact lenses may be mislabeled with the incorrect lens power.
Firm 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.
Root Cause
Process control
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of Illinois and Missouri, and the countries of Denmark, Germany, The Netherlands, Switzerland.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.