FDA.reportPublic FDA data

Precision Lens Ophthalmic

Primary DI
00817337000012
Brand
Precision Lens Ophthalmic
Company
Anika Therapeutics, Inc.
Model
600-801
Device description
0.8 ml, 12 mg/mL Sodium Hyaluronate
Published
2017-05-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LZPAid, Surgical, Viscoelastic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZPAid, Surgical, ViscoelasticOphthalmic3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P000046000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P000046000STAARVISC IIAnika Therapeutics, Inc.2001-04-18LZP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817337000012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817337000012008173370000128173370000120817337000012

GMDN Terms#

Term, Definition table
TermDefinition
Vitreous/aqueous humour replacement medium, intraoperativeA nonimplantable artificial fluid, semifluid, or viscoelastic substance intended to be used to replace the vitreous or aqueous humour within the eye to help facilitate the performance of ophthalmic surgery (e.g., to maintain the shape of the eyeball during the intervention, preserve tissue integrity, protect from surgical trauma, and/or to function as a tamponade during retinal reattachment). It may be supplied in a prefilled sterile syringe or other container. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
807613393
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817337000364NanoFx FURS-41012026-05-21
00817337000616Hyalomatrix60002322026-02-22
00817337000418Integrity Implant60001132026-01-05
00817337000425Integrity Implant60001142025-09-19
00866142000007Hydrelle685-0152014-09-30
08033549790738Epifilm Otologic653-20014170002018-02-19
08033549790745Epidisc 2pk Otologic 8mm653-30014171002018-02-19
08033549790752EpiDisc TM Perf Patch Kit653-16014171512018-02-19
08033549790769Merogel Injectable640-023CFN 15180002016-09-24
08033549790974Epifilm Otologic653-20014170002018-11-08
08033549790981Epidisc 2pk Otologic 8mm653-30014171002018-11-08
08033549790998EpiDisc TM Perf Patch Kit653-16014171512018-11-08
08033549791117MEROGEL 2pk 4x4cm65114115170022024-04-18
08033549791124MEROGEL 1PK 4x4cm65114015170002024-04-18
08033549791063Epifilm Otologic653-20014170002022-02-04
08033549790714Merogel Nasal Dressing/Sinus Stent &Otologic Packing 2pk 4x4cm651-14115170022018-02-19
08033549790721Merogel Nasal Dressing/Sinus Stent &Otologic Packing 4x4cm651-14015170002018-02-19
08033549790776MeroGel Otologic Packing 1x5cm651-14215171002018-02-19
08033549790950Merogel Nasal Dressing/Sinus Stent &Otologic Packing 2pk 4x4cm651-14115170022020-01-15
08033549790967Merogel Nasal Dressing/Sinus Stent &Otologic Packing 4x4cm651-14015170002020-01-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05050474755093HEALON ENDOCOAT PROJOHNSON & JOHNSON SURGICAL VISION, INC.LZP2025-08-20
05050474755116HEALON DUET PRO IIJOHNSON & JOHNSON SURGICAL VISION, INC.LZP2025-08-20
05050474807433HEALON PROJOHNSON & JOHNSON SURGICAL VISION, INC.LZP2024-04-08
05050474807440HEALON PROJOHNSON & JOHNSON SURGICAL VISION, INC.LZP2024-04-08
05050474807457HEALON GV PROJOHNSON & JOHNSON SURGICAL VISION, INC.LZP2024-04-08
05050474807464HEALON5 PROJOHNSON & JOHNSON SURGICAL VISION, INC.LZP2024-04-08
00763000837211Extended™ Reservoir 3.0mLMEDTRONIC MINIMED, INC.LZP2024-02-17
20763000837215Extended™ Reservoir 3.0mLMEDTRONIC MINIMED, INC.LZP2024-02-17
00763000837235Extended™ ReservoirMEDTRONIC MINIMED, INC.LZP2024-02-12
20763000837239Extended™ ReservoirMEDTRONIC MINIMED, INC.LZP2024-02-12
00763000837259Extended Reservoir™MEDTRONIC MINIMED, INC.LZP2024-02-12
10757770601728StableViscBausch & Lomb IncorporatedLZP2023-04-09
10757770601735TotalViscBausch & Lomb IncorporatedLZP2023-04-09
15060156070373BiolonALTACOR LIMITEDLZP2022-06-07
15060156070380BiolonALTACOR LIMITEDLZP2022-06-07
00817337000128OphthalinAnika Therapeutics, Inc.LZP2021-12-29
00866142000052AnikaviscAnika Therapeutics, Inc.LZP2021-12-29
00757770558360ClearViscBausch & Lomb IncorporatedLZP2021-05-10
05050474651654HEALON GV PROJOHNSON & JOHNSON SURGICAL VISION, INC.LZP2019-05-15
05050474651425HEALON DUET PROJOHNSON & JOHNSON SURGICAL VISION, INC.LZP2018-07-16
05050474636972HEALON PROJOHNSON & JOHNSON SURGICAL VISION, INC.LZP2018-06-25
05050474636989HEALON PROJOHNSON & JOHNSON SURGICAL VISION, INC.LZP2018-06-25
05050474636996HEALON5 PROJOHNSON & JOHNSON SURGICAL VISION, INC.LZP2018-06-25
00369918000008BiolonAMRING PHARMACEUTICALS INC.LZP2018-05-17
01369918000007BiolonAMRING PHARMACEUTICALS INC.LZP2018-05-17
00380651999077DUOVISCAlcon Laboratories, Inc.LZP2017-11-14
E314421004000SignatureMaterialise NVLZP2017-07-21
04711605585224UTF Hip StemUNITED ORTHOPEDIC CORP.LZP2017-05-26
E31442100400SignatureMaterialise NVLZP2016-09-24
00380651830042PROVISCAlcon Laboratories, Inc.LZP2015-03-31