FDA.reportPublic FDA data

Phacoemulsification system handpiece tip, single-use

Definition
A device that is attached to a dedicated handpiece for insertion into the eye to deliver energy (e.g., ultrasonic, piezoelectric), provided from a system generator, to perform phacoemulsification (a procedure for the liquefying and removal of the opaque lens nucleus in cataract surgery). It may facilitate, via the handpiece, the irrigation/suction needed for the removal of debris. This is a single-use device.
GUDID devices
144
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00380657403028Alcon, TurboSonics, MicroTipAlcon Laboratories, Inc.30RTS2016-09-24
00380657403042Alcon, TurboSonics, MicroTipAlcon Laboratories, Inc.30KTS2016-09-24
00380657408061Alcon, TurboSonics, Flared ABSAlcon Laboratories, Inc.80657408062016-09-24
00380657408375Alcon, TurboSonics, Flared ABS, MicroTipAlcon Laboratories, Inc.80657408372016-09-24
00380657408382Alcon, TurboSonics, Flared ABS, MicroTipAlcon Laboratories, Inc.80657408382016-09-24
00380657408399Alcon, TurboSonics, Flared ABS, MicroTipAlcon Laboratories, Inc.80657408392016-09-24
00380657502615Alcon, TurboSonics, Tapered ABS, MicroTipAlcon Laboratories, Inc.80657502612016-09-24
00380657502639Alcon, Kelman, TurboSonics, Tapered ABS, MicroTipAlcon Laboratories, Inc.80657502632016-09-24
00380657502646Alcon, Kelman, TurboSonics, Tapered ABS, MicroTipAlcon Laboratories, Inc.80657502642016-09-24
00380657508525Alcon, Kelman, TurboSonics, Mini-Flared ABSAlcon Laboratories, Inc.80657508522016-09-24
00380657508532Alcon, Kelman, TurboSonics, Mini-Flared ABSAlcon Laboratories, Inc.80657508532016-09-24
00380657511761Alcon, Ozil, TurboSonics, Mini-Flared ABSAlcon Laboratories, Inc.80657511762016-09-24
00380657511778Alcon, Ozil, TurboSonics, Mini-Flared ABSAlcon Laboratories, Inc.80657511772016-09-24
00380657511785Alcon, Ozil, TurboSonics, Mini-Flared ABSAlcon Laboratories, Inc.80657511782016-09-24
00380657511792Alcon, Ozil, TurboSonics, Flared ABSAlcon Laboratories, Inc.80657511792016-09-24
00380657517893Alcon, UltraChopperAlcon Laboratories, Inc.80657517892016-09-24
00380657520657Alcon, Kelman, TurboSonics, ABSAlcon Laboratories, Inc.80657520652016-09-24
00380657520664Alcon, Kelman, TurboSonics, ABSAlcon Laboratories, Inc.80657520662016-09-24
00380657900190Alcon, Kelman, TurboSonics, ABS, MicroTipAlcon Laboratories, Inc.80657900192016-09-24
00380657900206Alcon, TurboSonics, ABS, MicroTipAlcon Laboratories, Inc.80657900202016-09-24
00380657900220Alcon, TurboSonics, ABS, MicroTipAlcon Laboratories, Inc.80657900222016-09-24
00380657900237Alcon, TurboSonics, ABS, MicroTipAlcon Laboratories, Inc.80657900232016-09-24
05050474537095LAMINARJOHNSON & JOHNSON SURGICAL VISION, INC.OPOR0021G2016-09-02
05050474537156LAMINARJOHNSON & JOHNSON SURGICAL VISION, INC.OPOCR4520L2016-09-02
05050474537200LAMINARJOHNSON & JOHNSON SURGICAL VISION, INC.OPOCR3021L2016-09-02
05050474537217LAMINARJOHNSON & JOHNSON SURGICAL VISION, INC.OPOCR4521L2016-09-09
08717872030272Disposable infusion sleeve for 1.8 mm phaco needle including test chamber.D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.3009.IRD182020-02-13
08717872030289Disposable infusion sleeve for 2.2 mm phaco needle including test chamber.D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.3009.IRD222020-02-13
08717872030296Disposable infusion sleeve for 2.4 mm phaco needle including test chamber.D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.3009.IRD242020-02-13
08717872030302Disposable infusion sleeve for 2.8 mm phaco needle including test chamber.D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.3009.IRD282020-02-13
08717872030319Disposable test chamber for phaco handpieceD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.3007.D2020-11-19
08717872031439MICS 1.8 mm Disposable phaco set with 30° straight flared needleD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.8430.18SF12020-02-13
08717872031446MICS 1.8 mm Disposable phaco set with 45° straight flared needleD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.8445.18SF12020-02-17
087178720314532.2 mm Disposable phaco set with 30° straight flared needleD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.8430.22SF12020-02-17
087178720314602.2 mm Disposable phaco set with 45° straight flared needleD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.8445.22SF12020-02-17
087178720314772.4 mm Disposable phaco set with 30° straight flared needleD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.8430.24SF12020-02-17
087178720314842.4 mm Disposable phaco set with 45° straight flared needleD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.8445.24SF12020-02-17
087178720314912.8 mm Disposable phaco set with 30° straight flared needleD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.8430.28SF12020-02-17
087178720315072.8 mm Disposable phaco set with 45° straight flared needleD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.8445.28SF12020-02-17
0871787203303723G Disposable phaco fragmentation needle, incl. wrenchD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.8400.F1062021-05-12
0871787203304420G Disposable phaco fragmentation needle, incl. wrenchD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.8400.FT2021-05-12
08717872033358MICS 1.8 mm Disposable phaco set with 30° angled flared needle Note: Incision siD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.8430.18AF1 2021-05-12
087178720333652.2 mm Disposable phaco set with 30° angled flared needle Note: Incision size 2.D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.8430.22AF12021-05-12
087178720333722.4 mm Disposable phaco set with 30° angled flared needle Note: Incition size 2.D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.8430.24AF12021-05-12
087178720333892.8 mm Disposable phaco set with 30° angled flared needle Note: Incision size 2.D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.8430.28AF12021-05-12
08717872033402MICS 1.8 mm Disposable phaco set with 45° angled flared needle Note: Incision siD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.8445.18AF12021-05-12
087178720334192.2 mm Disposable phaco set with 45° angled flared needle Note: Incision size 2.D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.8445.22AF12021-05-12
087178720334332.4 mm Disposable phaco set with 45° angled flared needle Note: Incition size 2.D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.8445.24AF12021-05-12
087178720334402.8 mm Disposable phaco set with 45° angled flared needle Note: Incision size 2.D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.8445.28AF12021-05-12
10757770529206Bausch + LombBausch & Lomb IncorporatedBL31242026-04-30
10818255010043NAMICROVISION, INC.NA2018-01-17
10757770056931Bausch + LombBausch & Lomb IncorporatedDP8030S2016-11-04
10757770057259Bausch + LombBausch & Lomb IncorporatedDP8730S2016-09-25
10757770057273Bausch + LombBausch & Lomb IncorporatedDP55312016-09-24
10757770057389Bausch + LombBausch & Lomb IncorporatedBL31182016-09-24
10757770058263Bausch + LombBausch & Lomb IncorporatedBL3318S2016-09-25
10757770058270Bausch + LombBausch & Lomb IncorporatedBL3318AS2016-09-25
10757770058713Bausch + LombBausch & Lomb IncorporatedBL3420S2016-09-25
10757770058720Bausch + LombBausch & Lomb IncorporatedBL3420AS2016-09-25
1871787203303423G Disposable phaco fragmentation needle, incl. wrenchD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.8400.F1062021-05-12
1871787203304120G Disposable phaco fragmentation needle, incl. wrenchD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.8400.FT2021-05-12
18717872033355MICS 1.8 mm Disposable phaco set with 30° angled flared needle Note: Incision siD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.8430.18AF1 2021-05-12
187178720333622.2 mm Disposable phaco set with 30° angled flared needle Note: Incision size 2.D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.8430.22AF12021-05-12
187178720333792.4 mm Disposable phaco set with 30° angled flared needle Note: Incition size 2.D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.8430.24AF12021-05-12
187178720333862.8 mm Disposable phaco set with 30° angled flared needle Note: Incision size 2.D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.8430.28AF12021-05-12
18717872033409MICS 1.8 mm Disposable phaco set with 45° angled flared needle Note: Incision siD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.8445.18AF12021-05-12
187178720334162.2 mm Disposable phaco set with 45° angled flared needle Note: Incision size 2.D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.8445.22AF12021-05-12
187178720334302.4 mm Disposable phaco set with 45° angled flared needle Note: Incition size 2.D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.8445.24AF12021-05-12
187178720334472.8 mm Disposable phaco set with 45° angled flared needle Note: Incision size 2.D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.8445.28AF12021-05-12
18717872031443MICS 1.8 mm Disposable phaco set with 45° straight flared needleD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.8445.18SF12020-02-17
187178720314502.2 mm Disposable phaco set with 30° straight flared needleD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.8430.22SF12020-02-17
187178720314672.2 mm Disposable phaco set with 45° straight flared needleD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.8445.22SF12020-02-17
187178720314742.4 mm Disposable phaco set with 30° straight flared needleD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.8430.24SF12020-02-17
187178720314812.4 mm Disposable phaco set with 45° straight flared needleD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.8445.24SF12020-02-17
187178720314982.8 mm Disposable phaco set with 30° straight flared needleD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.8430.28SF12020-02-17
187178720315042.8 mm Disposable phaco set with 45° straight flared needleD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.8445.28SF12020-02-17
18717872030279Disposable infusion sleeve for 1.8 mm phaco needle including test chamber.D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.3009.IRD182020-02-13
18717872030286Disposable infusion sleeve for 2.2 mm phaco needle including test chamber.D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.3009.IRD222020-02-13
18717872030293Disposable infusion sleeve for 2.4 mm phaco needle including test chamber.D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.3009.IRD242020-02-13
18717872030309Disposable infusion sleeve for 2.8 mm phaco needle including test chamber.D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.3009.IRD282020-02-13