Recall Z-3282-2018 ยท HQL Intraocular Lens
Rayner Intraocular Lenses Limited
C-flex 570C +19.0D Intraocular Lens Product Usage: C-flex IOLs are designed to be surgically implanted into the capsular bag of the human eye as a replacement for the crystalline lens following phacoemulsification
| Date | Aug 9, 2018 |
| Status | Terminated |
| Reason | Firm become aware of reports of post-operative refractive errors following implantation of lenses. |
| Root cause | Error in labeling |
| Action | On August 31 the firm sent letters to all customers (health care facilities) that have received lenses in this batch and instructed to quarantine any remaining unused lenses from the C-flex 570C +19.0D batch 017100825. Replacement, reimbursement or substitution is offered (as appropriate). |
| Quantity | 49 |
| Distribution | US in the states of MO |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.