Recall Z-1338-2022 ยท HQL Intraocular Lens
Rayner Intraocular Lenses Ltd
RayOne Preloaded Hydrophilic Acrylic IOL Injection Systems containing one MICS injection system with Intraocular Lens: (1) Outer carton labeled as Rayner RayOne EMV US, REF RAO200E, SE: +19.00D, Sph: +19.00D; and (2) Inner primary device packaging labeled as Rayner RayOne EMV US, REF RAO200E, SE: +21.00D, Sph: +21.00D.
| Date | May 13, 2022 |
| Status | Open, Classified |
| Reason | The outer package is mislabeled and the package contains a different IOL strength. |
| Root cause | Under Investigation by firm |
| Action | The recalling firm sent two emails to the importer warehouse on 5/12/2022 instructing them to freeze all units of the affected lots from further distribution, provide the number of units in inventory, and to provide the accounts who have been sent the units so they can track them. On 5/13/2022, the recalling firm sent an email to their sales team requesting all unused units from the affected batch be returned to a designated warehouse (the importer, which was listed as a direct account). The email included an attached letter and a response form that the sales team was to send to any of their |
| Quantity | 162 IOLs |
| Distribution | US Nationwide distribution in the states of AZ, CA, FL, GA, IN, MI, MN, MO, ND, NJ, OK, TN, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.