Recall Z-1455-2025 ยท MVN Lens, Contact, (Disposable)
CooperVision, Inc.
Brand Names: MyDay Toric, LensCrafters One Day Premium Daily Disposable Contact Lenses For Astigmatism, Pearle Vision 1 Day Premium For Astigmatism, REVEAL 1-DAY TORIC, Vision Source Reveal Toric, Voyant 1-Day Premium Toric. Brand Names (OUS only): CADENCE DELUXE 1-DAY TORIC, DUBLAN PREMIUM OXYGEN 1 DAY TORIC, EV LINARIAL TORIC (30), EYEXPERT PURE ASTIGMATISM (30), LENTI!!AS A ASTIGMATISMO 30PK, L
| Date | Mar 26, 2025 (initiated Feb 27, 2025) |
| Status | Open, Classified |
| Reason | a limited number of lots were manufactured with an incorrect cylinder power. |
| Root cause | Process control |
| Action | On February 27, 2025, URGENT MEDICAL DEVICE CORRECTION letters were sent to direct consignees. We request you take the following actions: 1. Please examine your inventory/product shelf for any of the provided affected lot numbers. The lot number can be found on the back panel of the carton below the expiration date. (Carton lots 19346502595028, 19346502613028, 21545502813013, and 21512501331524) 2. While trials lenses are not impacted by this action, if your patients have discarded the carton, the affected product can be identified by examining the lot number printed on the blister. This numbe |
| Quantity | 33990 lenses (17010 US, 16980 OUS) |
| Distribution | Domestic: CA, CO, FL, IL, KY, MI, NC, NE, NJ, NY, OH, OR, UT, VA, WA. International: Australia, Belgium, Canada, Czech Republic, Denmark, France, Germany, Ireland, Italy, Luxembourg, Netherlands, New Zealand, Norway, Poland, Portugal, Spain, Sweden, Switzerland, and United Kingdom. |
| FDA record | Open on fda.gov |