FDAClass IIOctober 10, 2018

C-flex 570C +19.0D Intraocular Lens Product Usage recall

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…

Why was C-flex 570C +19.0D Intraocular Lens Product Usage recalled?

Firm become aware of reports of post-operative refractive errors following implantation of lenses.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Batch 017100825 Lens #'s: 01710082501, 01710082502, 01710082503, 01710082504, 01710082505, 01710082506, 01710082507, 01710082508, 01710082509, 01710082510, 01710082511, 01710082512, 01710082513, 01710082514, 01710082515, 01710082516, 01710082517, 01710082518, 01710082519, 01710082520, 01710082521, 01710082522, 01710082523, 01710082524, 01710082525, 01710082526, 01710082527, 01710082528, 01710082529, 01710082530, 01710082531, 01710082532, 01710082533, 01710082534, 01710082535, 01710082536, 01710082537, 01710082538, 01710082539, 01710082540, 01710082541, 01710082542, 01710082543, 01710082544, 01710082545, 01710082546, 01710082547, 01710082548, and 01710082549.

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…
Recalling firm
Rayner Intraocular Lenses Limited
Quantity
49
Distribution
US in the states of MO
Recall date
October 10, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls