FDA.reportPublic FDA data

COOPERVISION Manufacturing Puerto Rico, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
26401283002911336COOPERVISION Manufacturing Puerto Rico, LLC1N2026-01-01500 ROAD 584, LOT 7 AMUELAS INDUSTRIAL PARK Juana Diaz PR US 00795

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
280921136168390P890023H55 HYDROPHILIC CONTACT LENSLPM1989-09-19
280922002855707P780007HYDRON HYDROPHILIC CONTACT LENSLPM1979-04-06
280921785821755P080011BIOFINITY (COMFILCON A)LPM2008-11-19
280921799310638K984046BIOMEDICS 55 (OCUFILCON D) UV BLOCKING SOFT (HYDROPHILIC) CONTAC LENSLPL1999-01-21
280921265821072K982947BIOMEDICS 55 (OCUFILCON D) UV BLOCKING SOFT (HYDROPHILIC) CONTACT LENSLPL1999-01-29
280922063762191K972303OSCULAR SCIENCES/ AMERICAN HYDRON, INC DAILY WEAR SOFT CONTACT LENSLPL1997-08-20
280921563727595K942214H55 HYDROPHILIC CONTACT LENSLPL1994-07-28
280921664067048K220070MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact LensLPL2022-02-04
280921419013554K213164Avaira VitalityLPL2021-10-26
280921112728322K190965MyDayLPL2019-04-29
280921478853846K160803Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact LensLPL2016-07-13
280921687022395K131378SUS (STENFILCON A) CONTACT LENSLPL2013-08-30
280921485950811K091339BIOMEDICS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENSLPL2010-01-05
280921989913368K061948PROCLEAR (OMAFILCON A) DAILY DISPOSABLE/DAILY WEAR SOFT CONTACT LENSMVN2006-11-22
280921800028267K052560BIOFINITY (COMFILCON A) SOFT CONTACT LENSLPL2005-12-06
280921755612706K020389BIOMEDICS 52 (OCUFILCON B) UV BLOCKING DAILY WEAR SOFT CONTACT LENSMVN2002-06-04
280921565174338K003136OCULAR SCIENCES, INC. BIOMEDICS 52 (OCUFILCON D) UV BLOCKING DAILY WEAR SOFT CONTACT LENSLPL2001-01-06

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LPL142022-02-04
LPM42008-11-19
MVN22006-11-22