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
Reported: October 10, 2018 Initiated: August 9, 2018 #Z-3282-2018
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.
Details
- Recalling Firm
- Rayner Intraocular Lenses Limited
- Units Affected
- 49
- Distribution
- US in the states of MO
- Location
- Worthing
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Rayner Intraocular Lenses Limited. Units affected: 49.
Why was this product recalled? ▼
Firm become aware of reports of post-operative refractive errors following implantation of lenses.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 10, 2018. Severity: Moderate. Recall number: Z-3282-2018.
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