Z-0691-2018Class III

Biofinity XR Toric contact lenses 8.7/14.5 - 6PK Biofinity XR Toric (comfilcon A) Soft (Hydrophilic) Contact...

Name: Z-0691-2018 Biofinity XR Toric contact lenses 8.7/14.5 - 6PK Biofinity XR Toric (comfilcon A) Soft (Hydrophilic) Contact...
Creator: CooperVision Inc.
Published: 2017-09-01
License: https://open.fda.gov/license/

CooperVision, Inc. / initiated 2017-09-01 / Terminated / root cause: manufacturing process

FDA source

CooperVision Inc. began a recall of Biofinity XR Toric contact lenses 8.7/14.5 - 6PK Biofinity XR Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for the correction of... on 2017-09-01. FDA classified it as Class III and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0691-2018
Classification: Class III
Status: Terminated
Initiated: 2017-09-01
Posted: 2018-02-23
Terminated: 2018-07-30
Recalling firm: CooperVision, Inc.
Product: Biofinity 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.
Product code: LPM Lenses, Soft Contact, Extended Wear
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.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Notifications 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 commerce: 120
Distribution: USA Distribution
Product codes and lots: Exp. date 2017-07-11; Lots: R12497769, R12519016, R12508969, R12496191, R12514162, R12518889, R12483347, R12518980, R12496182, R12496192, R12498168, R12502974, R12496166, R12496196, R12501147, R12508370, R12518890, R12518978.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0691-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0691-2018	Class III	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-23

Product code LPM

K052560Class IIBiofinity (Comfilcon a) Soft Contact LensCooperVision, Inc. / cleared 2005-12-06

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)