Z-3282-2018Class II

C-flex 570C +19.0D Intraocular Lens

Name: Z-3282-2018 C-flex 570C +19.0D Intraocular Lens
Creator: Rayner Intraocular Lenses Limited
Published: 2018-08-09
License: https://open.fda.gov/license/

Rayner Intraocular Lenses Limited / initiated 2018-08-09 / Terminated / root cause: labeling and UDI

FDA source

Rayner Intraocular Lenses Limited began a recall of 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... on 2018-08-09. FDA classified it as Class II and gives the reason as "Firm become aware of reports of post-operative refractive errors following implantation of lenses". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-3282-2018
Classification: Class II
Status: Terminated
Initiated: 2018-08-09
Posted: 2018-09-28
Terminated: 2020-11-24
Recalling firm: Rayner Intraocular Lenses Limited
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
Product code: HQL Intraocular Lens
Reason for recall: Firm become aware of reports of post-operative refractive errors following implantation of lenses.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: On August 31 the firm sent letters to all customers (health care facilities) that have received lenses in this batch and instructed to quarantine any remaining unused lenses from the C-flex 570C +19.0D batch 017100825. Replacement, reimbursement or substitution is offered (as appropriate).
Quantity in commerce: 49
Distribution: US in the states of MO
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3282-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3282-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-09-28

Product code HQL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)