Recall Z-3282-2018— Rayner Intraocular Lenses Limited
Class II · Terminated
Class II FDA medical device recall by Rayner Intraocular Lenses Limited, initiated 2018-08-09, terminated 2020-11-24. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..
- Recalling firm
- Rayner Intraocular Lenses Limited
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-08-09
- Terminated
- 2020-11-24
- Firm location
- Worthing, United Kingdom
Product 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 for recall
Firm become aware of reports of post-operative refractive errors following implantation of lenses.
Data sourced from openFDA. This site is unofficial and independent of the FDA.