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U.S. Department of Health and Human Services

Class 2 Device Recall Cflex Intraocular Lens

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 Class 2 Device Recall Cflex Intraocular Lenssee related information
Date Initiated by FirmAugust 09, 2018
Create DateSeptember 28, 2018
Recall Status1 Terminated 3 on November 24, 2020
Recall NumberZ-3282-2018
Recall Event ID 80943
PMA NumberP060011 
Product Classification intraocular lens - Product Code HQL
ProductC-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
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.  
FEI Number 3012304651
Recalling Firm/
Manufacturer		 Rayner Intraocular Lenses Limited
The Ridley Innovation Centre
10 Dominion Way
Worthing United Kingdom
Manufacturer Reason
for Recall		Firm become aware of reports of post-operative refractive errors following implantation of lenses.
FDA Determined
Cause 2		Error in labeling
ActionOn 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 Commerce49
DistributionUS in the states of MO
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA DatabasePMAs with Product Code = HQL
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