FDA.reportPublic FDA data

Biolon

Primary DI
15060156070380
Brand
Biolon
Company
ALTACOR LIMITED
Model
version 1
Catalog number
62501
Device description
Viscoelastic surgical aid
Published
2022-06-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

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
P960011001

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P960011001BIOLON 1% SODIUM HYALURONATE VISCOELASTIC SURGICAL AID FLUIDAltacor , Ltd.1998-07-16LZP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15060156070380PackageGS1185In Commercial Distribution
15060156070373PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1506015607038015060156070380
1506015607037315060156070373

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Total Volume1Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Special Storage Condition, Specify: Do not Freeze
Special Storage Condition, Specify00Special Storage Condition, Specify: Protect from light
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+4401182210150pv@altacor-pharma.com

Regulatory Flags#

DUNS number
346153906
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15060156070373Biolonversion 1625012022-06-07

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
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
00817337000012Precision Lens OphthalmicAnika Therapeutics, Inc.LZP2017-05-18
E31442100400SignatureMaterialise NVLZP2016-09-24
00380651830042PROVISCAlcon Laboratories, Inc.LZP2015-03-31