Recall Z-1014-2023 ยท LPL Lenses, Soft Contact, Daily Wear
CooperVision, Inc.
MyDay Toric (90-pack) Reveal 1 Day Toric (90-pack) Soft (hydrophilic) Contact Lens (daily wear). Single Use.
| Date | Jan 24, 2023 (initiated Dec 27, 2022) |
| Status | Open, Classified |
| Reason | Lenses may be of the incorrect power. A patient who uses an affected lens may experience poor visual acuity. |
| Root cause | Process control |
| 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. P |
| Quantity | 6,570 lenses |
| Distribution | Distribution to US states of CA, FL, IA, KY, NC, NY, OH, OR, WI; Canada and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131378 | SUS (STENFILCON A) CONTACT LENS CooperVision, Inc., Aug 30, 2013 |