FDA.reportPublic FDA data

pioli™ IOL Delivery System

Primary DI
10814899027454
Brand
pioli™ IOL Delivery System
Company
AST PRODUCTS, INC.
Model
PIOLI-O
Device description
Single-use, Sterile Intraocular Lens Injector Only for the Insertion of IOL Models Validated for Use with this Device as Indicated in the IOL Approved Labeling
Published
2026-04-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MSSFolders And Injectors, Intraocular Lens (Iol)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MSSFolders And Injectors, Intraocular Lens (Iol)Ophthalmic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172228000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172228000pioli IOL Delivery SystemAst Products, Inc.2017-12-15MSS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10814899027454PrimaryGS10
00814899027457Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081489902745410814899027454
00814899027457008148990274578148990274570814899027457

GMDN Terms#

Term, Definition table
TermDefinition
Manual intraocular lens injector, single-useA hand-held manual ophthalmic surgical instrument designed to expel (launch) a prepared (folded) intraocular lens (IOL) from an attached IOL insertion cartridge into the anterior or posterior chamber of the eye during ophthalmic implantation surgery. It has a central plunger that is activated by a precise mechanism (e.g., a screw thread) and a mechanism at the distal end to hold/grip the insertion cartridge; it is typically made of plastic materials. This is a single-use device.

Regulatory Flags#

DUNS number
611655440
Device count
10
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10814899027003lioli™ IOL Delivery SystemLIOLI-182018-09-14
10814899027010lioli™ IOL Delivery SystemLIOLI-222018-09-14
10814899027027lioli™ IOL Delivery SystemLIOLI-242018-09-14
10814899027041pioli™ IOL Delivery SystemPIOLI-D2018-09-14
10814899027072bioli™ IOL Delivery SystemBIOLI-D2020-12-07
10814899027126bioli™ IOL Delivery SystemBIOLI-C2020-12-07
10814899027133bioli™ IOL Delivery SystemBIOLI-rC2020-12-07
10814899027164bioli™ IOL Delivery SystemBIOLI-A12022-10-03
00814899027167bioli™ IOL Delivery SystemBIOLI-A12022-10-03
00814899027075bioli™ IOL Delivery SystemBIOLI-D2020-12-07
00814899027129bioli™ IOL Delivery SystemBIOLI-C2020-12-07
00814899027136bioli™ IOL Delivery SystemBIOLI-rC2020-12-07
10814899027065BL-Cart™ IOL Delivery CartridgeType D2019-10-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10757770602497EyeGility™ InserterBausch & Lomb IncorporatedMSS2026-04-05
10757770618115EyeGility™ InserterBausch & Lomb IncorporatedMSS2026-04-05
07630055212023ACCUJECT 2.2-1P INJECTOR SETMedicel AGMSS2025-12-09
07630055214584ACCUJECT injector Set 2.1-1PMedicel AGMSS2025-09-30
10818806021016RxSight Insertion DeviceRXSIGHT, INC.MSS2024-11-12
00818806021019RxSight Insertion DeviceRXSIGHT, INC.MSS2024-11-12
00844369016858I9011SLenstec Barbados IncMSS2024-05-06
00844369016865I9012Lenstec Barbados IncMSS2024-05-06
00844369016872I9012FSLenstec Barbados IncMSS2024-05-06
00844369018944LC16Lenstec Barbados IncMSS2024-05-06
00844369018968LC24Lenstec Barbados IncMSS2024-05-06
00844369018975CART45SLenstec Barbados IncMSS2024-05-06
00844369018982CARTMLenstec Barbados IncMSS2024-05-06
00757770520183BLIS-X1Bausch & Lomb IncorporatedMSS2024-03-04
00757770523337BLIS-X0Bausch & Lomb IncorporatedMSS2024-03-04
00757770488964Cystalsert Delivery SystemBausch & Lomb IncorporatedMSS2024-01-18
00757770529032Sofport Easy-Load Lens Delivery System EZ-24Bausch & Lomb IncorporatedMSS2024-01-18
07630055214850Accuject REFRA 2.9 InjectorMedicel AGMSS2023-12-08
07630055211934VISCOJECT 2.2 INJECTOR-SETMedicel AGMSS2023-12-01
07630055211941VISCOJECT 1.8 Injector setMedicel AGMSS2023-12-01
20840311300017MicroStaarSTAAR SURGICAL COMPANYMSS2023-06-15
20840311300024MicroStaarSTAAR SURGICAL COMPANYMSS2023-06-15
00840311344796MicroStaarSTAAR SURGICAL COMPANYMSS2023-06-15
00840311344802MicroStaarSTAAR SURGICAL COMPANYMSS2023-06-15
10840311300010MicroStaarSTAAR SURGICAL COMPANYMSS2023-06-15
10840311300027MicroStaarSTAAR SURGICAL COMPANYMSS2023-06-15
00840311300013MicroStaarSTAAR SURGICAL COMPANYMSS2023-06-15
00840311300020MicroStaarSTAAR SURGICAL COMPANYMSS2023-06-15
00841668142851ASICO ROYALE III INJECTOR W/ LONG SPRINGKATENA PRODUCTS, INC.MSS2022-12-13
00841668142868ASICO ROYALE III INJECTORKATENA PRODUCTS, INC.MSS2022-12-13