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U.S. Department of Health and Human Services

Class 3 Device Recall Biofinity XR Toric

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 Class 3 Device Recall Biofinity XR Toricsee related information
Date Initiated by FirmSeptember 01, 2017
Create DateFebruary 23, 2018
Recall Status1 Terminated 3 on July 30, 2018
Recall NumberZ-0691-2018
Recall Event ID 79073
510(K)NumberK052560 
PMA NumberP080011S029 
Product Classification Lenses, soft contact, extended wear - Product Code LPM
ProductBiofinity XR Toric contact lenses 8.7/14.5 - 6PK Biofinity XR Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for the correction of ametropia (myopia or hyperopia) with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -5.75 diopters. The Biofinity (comfilcon A) Soft (Hydrophilic) Contact Lenses have been approved for extended wear for up to 6 nights /7 days of continuous wear. It is recommended that the contact lens wearer first be evaluated on a daily wear schedule. If successful, then a gradual introduction of extended wear can be followed as determined by the prescribing Eye Care Practitioner.
Code Information Exp. date 2017-07-11; Lots: R12497769, R12519016, R12508969, R12496191, R12514162, R12518889, R12483347, R12518980, R12496182, R12496192, R12498168, R12502974, R12496166, R12496196, R12501147, R12508370, R12518890, R12518978.
Recalling Firm/
Manufacturer		 CooperVision Inc.
180 Thruway Park Dr
W Henrietta NY 14586-9798
For Additional Information ContactChris Izzo
585-756-9273
Manufacturer Reason
for Recall		The firm identified a labeling error affecting Made-To-Order (MTO) Biofinity XR Toric blister labels. The primary blister reads Biofinity Multifocal Toric in error, and should read Biofinity XR Toric. The outer carton correctly reads Biofinity XR Toric.
FDA Determined
Cause 2		Employee error
ActionNotifications were sent with instructions to examine inventory, discard any affected inventory, and contact the firm for credit or replacement. For further questions, please call (585) 756-9273.
Quantity in Commerce120
DistributionUSA Distribution
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.
510(K) Database510(K)s with Product Code = LPM
PMA DatabasePMAs with Product Code = LPM
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