Rayner C-flex Intraocular Lens Recall Due to Refractive Errors
Rayner Intraocular Lenses Limited is recalling 49 C-flex 570C +19.0D intraocular lenses distributed in Missouri due to reports of post-operative refractive errors.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (intraocular lens) where injury (refractive errors) has been reported, but the source does not indicate hospitalization or serious injury, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Rayner Intraocular Lenses Limited is recalling 49 units of the C-flex 570C +19.0D Intraocular Lens. These lenses are designed to be surgically implanted into the capsular bag of the human eye as a replacement for the crystalline lens following phacoemulsification. The recall is limited to Batch 017100825, with specific lens numbers ranging from 01710082501 to 01710082549.
The recall was initiated after the firm became aware of reports of post-operative refractive errors following the implantation of these lenses. The affected units were distributed in the United States, specifically in the state of Missouri.
Consumers and healthcare providers who have used or possess these specific lenses should contact Rayner Intraocular Lenses Limited for further instructions on how to proceed. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The recalled product
- 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
- Manufacturer
- Rayner Intraocular Lenses Limited
- Hazard
- Affected units
- 49
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Batch 017100825 Lens #'s: 01710082501
- 01710082502
- 01710082503
- 01710082504
- 01710082505
- 01710082506
- 01710082507
- 01710082508
- 01710082509
- 01710082510
- 01710082511
- 01710082512
- 01710082513
- 01710082514
- 01710082515
- 01710082516
- 01710082517
- 01710082518
- 01710082519
- 01710082520
Distribution
Distributed in 1 state:
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