COOPERVISION, INC.

Entity profile compiled from public source records

Public Record Profile Registrations: 14 510(k) filings: 1 Recalls: 1

Known Identifiers & Locations

FEI Numbers 1314956, 3002806417, 3002807465, 3002807783, 3002911336, 3003981983, 3005087645, 3005724763, 3006514242, 3008586477, 3009108089, 3011771819, 3012123291, 3013398957
Owner Operator Numbers 9929062
Locations Covered Alajuela, CR; CARLSBAD, CA, US; EASTLEIGH Hampshire, GB; Eastleigh Hampshire, GB; Fareham Hampshire, GB; Gilbert, AZ, US; Gyal Budapest, HU; Juana Diaz, PR, US; SCOTTSVILLE, NY, US; SHERBROOKE Quebec, CA; SOUTHAMPTON Hampshire, GB; Victor, NY, US; W Henrietta, NY, US; Wide Lane Southampton, GB

Registered Establishments (14)

Registration # Establishment Name Location Establishment Type(s) Action
1314956 COOPERVISION, INC. SCOTTSVILLE, NY, US Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device View Details
2640128 COOPERVISION Manufacturing Puerto Rico, LLC Juana Diaz, PR, US Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device View Details
3003981983 COOPERVISION MANUFACTURING, LTD. EASTLEIGH Hampshire, GB Manufacture Medical Device View Details
3005087645 SYNERGEYES, INC. CARLSBAD, CA, US Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device View Details
3005724763 COOPERVISION INC. W Henrietta, NY, US Repack or Relabel Medical Device View Details
3006514242 CooperVision Manufacturing Ltd Fareham Hampshire, GB Export Device to the United States But Perform No Other Operation on Device View Details
3008586477 CooperVision Manufacturing, LTD. Wide Lane Southampton, GB Repack or Relabel Medical Device View Details
3009108089 CooperVision CL KFT Gyal Budapest, HU Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device View Details
3011771819 CooperVision, Inc. Victor, NY, US Complaint File Establishment per 21 CFR 820.198 View Details
3012123291 CooperVision Manufacturing Costa Rica SRL Alajuela, CR Manufacture Medical Device View Details
3013398957 Paragon Vision Sciences, Inc. Gilbert, AZ, US Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device View Details
9612500 BLANCHARD VISION CORP. SHERBROOKE Quebec, CA Manufacture Medical Device for Another Party (Contract Manufacturer) View Details
9614374 CooperVision Limited Eastleigh Hampshire, GB Develop Specifications But Do Not Manufacture At This Facility View Details
9614392 COOPERVISION MANUFACTURING, LTD. SOUTHAMPTON Hampshire, GB Manufacture Medical Device View Details

510(k) Premarket Notifications (1)

Submission # Device Name Decision Date Decision Description Action
K881095 KOI(TM) INSTRUMENT TRAYS 1988-04-06 Substantially Equivalent View Details

FDA Recall History (1)

Recall # Product Description Initiation Date Status Action
Z-0044-2012 AVAIRA Toric (enfilcon A) TORIC soft (Hydrophilic) Contact Lenses, 6 SOFT CONTACT LENSES FOR ASTIGMATISM, CooperVision, Scottsville, NY 14546 USA; Juana Diaz, PR 00795 USA; Hamble SO31, 4RF, UK; Device Listing # D033736. Product Usage: 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 -10.00 diopters. The AVAIRA Soft Contact Lens is indicated for single - use disposable wear and daily wear. When prescribed for frequent replacement, the lens may be disinfected using a chemical or hydrogen peroxide disinfecting system. Reason: This recall was initiated because of the unintended presence of a residue (silicone oil) on lenses from certain lots of Avaira Toric contact lenses. The company received complaints of temporary hazy or blurry vision and discomfort, most likely caused by transient or reversible swelling of the surface layer of the cornea, which is known as corneal epithelial edema. Corneal epithelial edema results when there is insufficient oxygen to the eye, which may be caused by the presence of residue on the lens. Through laboratory testing and investigation, the company determined the cause of the corneal epithelial edema was a small amount of residue (silicone oil) on the lens. 2011-08-19 Terminated View Details

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