MyDay Toric (90-pack) Reveal 1 Day Toric (90-pack) Soft (hydrophilic) Contact Lens (daily wear). Single Use.
FDA Recall Z-1014-2023 · Posted 2023-01-24
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Recalling FirmCooperVision, Inc.
Recall StatusOpen, Classified
Product CodeLPL
Date Initiated2022-12-27
Product Quantity6,570 lenses
Reason for Recall
Lenses may be of the incorrect power. A patient who uses an affected lens may experience poor visual acuity.
Firm Action
On December 27, 2022, the firm notified affected wholesale/distributor and Eye Care Practitioner consignees via Urgent Medical Device Correction letters.
Customers were instructed to stop any further distribution of product from affected lot numbers and dispose of any affected product still in inventory. Customers may also return product. Customers who are affected by this recall are eligible for credit or replacement.
Distributors and Eye Care Practitioners should also contact downstream Eye Care Practitioner customers as well as patients who have received product from the affected lots.
Patients with questions may contact CooperVision's Customer Service team at 800-341-2020, 9:00 AM 7:00 PM ET, Monday Friday, or they can visit CooperVision s website at coopervision.com/our-company/contact-us/complaint.
Root Cause
Process control
Distribution Pattern
Distribution to US states of CA, FL, IA, KY, NC, NY, OH, OR, WI; Canada and Japan.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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