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Recall Observatory FDA recall evidence

Device 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

Z-3282-2018

August 09, 2018

Class II

Product summary

Firm
Rayner Intraocular Lenses Limited
Event
Event 80943
Status
Terminated
Classification
Class II
Quantity
49
Official record key
device-enforcement:Z-3282-2018

Official wording

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

Code information: 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.

Distribution pattern: US in the states of MO

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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