Class 2 Device Recall Cflex Intraocular Lens

• Date Initiated by Firm: August 09, 2018
• Create Date: September 28, 2018
• Recall Status: Terminated on November 24, 2020
• Recall Number: Z-3282-2018
• Recall Event ID: 80943
• PMA Number: P060011
• Product Classification: intraocular lens - Product Code HQL
• 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
• 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.
• 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: 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
• Total Product Life Cycle: TPLC 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 Database: PMAs with Product Code = HQL and Original Applicant = RAYNER INTRAOCULAR LENSES LTD.