FDA Recall
Terminated
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
Recall: Z-3282-2018
·
Initiated August 9, 2018
Recall
- Recall Number
- Z-3282-2018
- Event Number
- 80943
- Firm
- Rayner Intraocular Lenses Limited The Ridley Innovation Centre 10 Dominion Way Worthing United Kingdom
- FEI Number
- 3012304651
- Product Code
- HQL
- Status
- Terminated
- Root Cause
- Error in labeling
- Initiated
- August 9, 2018
- Terminated
- November 24, 2020
Description
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
Reason
Firm become aware of reports of post-operative refractive errors following implantation of lenses.
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).
Distribution
US in the states of MO
Quantity
49