FDA.reportPublic FDA data

Intraocular retractor, single-use

Definition
A sterile, dedicated ophthalmic surgical instrument intended to be used explicitly for the temporary mechanical retraction/dilatation of intraocular tissues (e.g., iris) during ophthalmic surgery. It is typically a self-retaining ring/frame or a small hook-like device which may include a retention bead, and is usually designed to be manipulated using another ophthalmic instrument. This is a single-use device.
GUDID devices
78
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00813059013927XpandDiamatrix3467222019-10-24
00813059018403Diamatrix LtdDiamatrixDIAX22022-10-31
00841668114339Disposable Iris RetractKATENA PRODUCTS, INC.K20-38902020-09-14
00841668114346Disposable Iris RetractKATENA PRODUCTS, INC.K20-38922020-09-14
00841668143452MAXIRIS FLEXIBLE IRIS RETRACTOR PACK/5KATENA PRODUCTS, INC.AS-92552022-12-13
00841668143469MAXIRIS AKAHOSHI FLAT IRIS RETRACT PK/5KATENA PRODUCTS, INC.AS-92562022-12-13
00841668143476MAXIRIS AKAHOSHI TW FIBR IRIS/CAP RETRACKATENA PRODUCTS, INC.AS-92572022-12-13
00845819000458OASIS® Iris ExpanderOASIS MEDICAL, INC.9625, 9625-S2023-06-30
00845819005200Disposable Instruments OASIS MEDICAL, INC.9700, 9700-S2023-06-30
00850003089003N/AOptalmed, LLC70012021-02-01
00850003089010N/AOptalmed, LLC70022021-02-01
00850003089041N/AOptalmed, LLC70042021-02-01
00850003089058N/AOptalmed, LLC70132021-02-01
00850003089072N/AOptalmed, LLCRx52132021-02-08
00850003089089N/AOptalmed, LLCRx5067B-52021-02-08
00850003089201N/AOptalmed, LLC30-134-62021-03-10
00850003089355N/AOptalmed, LLC70312025-07-07
00853480006129Fiber Optic Light GuideESCALON MEDICAL CORP.Iris Retractor, 20 ga2016-01-14
07612717012233Alcon GrieshaberAlcon Laboratories, Inc.611.752020-08-19
08052276027054Set of 4 Iris RetractorsAKTIVE SRLAK-04902024-01-11
08052276027061Set of 5 Iris RetractorsAKTIVE SRLAK-04922024-01-11
08717872009643Iris Retractor.D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.40202021-01-07
10818255010104N/AMICROVISION, INC.N/A2018-04-04
10818255010111N/AMICROVISION, INC.N/A2018-04-04
10818255010227N/AMICROVISION, INC.N/A2018-04-04
10818255010234N/AMICROVISION, INC.N/A2018-04-04
10844685000040Malyugin Ring System 7.0mmMICROSURGICAL TECHNOLOGY, INC.MAL-00022018-09-18
10844685006127Malyugin Ring System 2.0, 6.25mmMICROSURGICAL TECHNOLOGY, INC.MAL-10012018-09-18
10844685006134Malyugin Ring System 2.0, 7.0mmMICROSURGICAL TECHNOLOGY, INC.MAL-10022018-09-18
10844685006325MST Capsule Retractor, Chang Modification 4-PackMICROSURGICAL TECHNOLOGY, INC.MCR-00022018-09-16
13700773724984IRIS RETRACTORSFCI S A S FCI 20 22S9.50152021-05-29
30886158007037Visitec®Beaver-Visitec International, Inc.5870002022-01-26
00850003089362N/AOptalmed, LLC70312025-07-07
00817489026267Disposable Iris Retractor HooksKATALYST SURGICAL LLCD4176-52025-04-28
00194613010942MSI Precision Specialty InstrumentsMed Saver, Inc.5-54919S-DS2024-08-15
08056477550502Set of 5 Iris RetractorsAKTIVE SRLAK-04922024-01-11
08058340220970Set of 4 Iris RetractorsAKTIVE SRLAK-04902024-01-11
10845819000455OASIS® Iris ExpanderOASIS MEDICAL, INC.9625, 9625-S2023-06-30
10845819005207Disposable Instruments OASIS MEDICAL, INC.9700, 9700-S2023-06-30
00813059018397Diamatrix LtdDiamatrixDIAX22022-10-31
00886158007036Visitec®Beaver-Visitec International, Inc.5870002022-01-26
00886158007043Visitec® I-Ring®Beaver-Visitec International, Inc.5870012022-01-20
17290017069002APX 200APX OPHTHALMOLOGY LTD2002021-04-14
10850003089208N/AOptalmed, LLC30-134-62021-03-10
18717872009640Iris Retractor.D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.40202021-01-07
10850003089086N/AOptalmed, LLCRx5067B-52021-02-08
00850003089218N/AOptalmed, LLC70012021-02-01
00850003089225N/AOptalmed, LLC70042021-02-01
10850003089017N/AOptalmed, LLC70022021-02-01
10850003089055N/AOptalmed, LLC70132021-02-01
18717872009657Iris Retractor.D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.40202021-01-07
00190660197179Ambler SurgicalAMBLER SURGICAL CORP.Iris retractors2021-01-04
00190660197186Ambler SurgicalAMBLER SURGICAL CORP.Iris retractors2021-01-04
00190660201715Ambler SurgicalAMBLER SURGICAL CORP.Iris retractors2021-01-04
00190660201722Ambler SurgicalAMBLER SURGICAL CORP.Iris retractors2021-01-04
00841668125397Disposable Iris RetractKATENA PRODUCTS, INC.K20-38902020-09-14
00841668125403Disposable Iris RetractKATENA PRODUCTS, INC.K20-38922020-09-14
07612717012226Alcon GrieshaberAlcon Laboratories, Inc.611.742020-08-19
17612717012230Alcon GrieshaberAlcon Laboratories, Inc.611.752020-08-19
00192896093881HEARTLINE RETRACTOR BLADESONTEC INSTRUMENTS, INC.2800-8052019-03-07
00192896093898HEARTLINE RETRACTOR BLADESONTEC INSTRUMENTS, INC.2800-8072019-03-07
00813059012166XpandDiamatrix1467012019-10-24
00813059013934XpandDiamatrix3467222019-10-24
20844685000023Malyugin Ring System 6.25mmMICROSURGICAL TECHNOLOGY, INC.MAL-00012018-09-18
20844685004571Medical Device Anterior Capsule RetractorMICROSURGICAL TECHNOLOGY, INC.MCR-00012018-09-16
20844685004878Medical Device Iris ExpanderMICROSURGICAL TECHNOLOGY, INC.MIH-00012018-09-16
30844685000020Malyugin Ring System 6.25mmMICROSURGICAL TECHNOLOGY, INC.MAL-00042018-09-18
00844685000029Malyugin Ring System 6.25mmMICROSURGICAL TECHNOLOGY, INC.MAL-0001-12018-09-18
00844685000043Malyugin Ring System 7.0mmMICROSURGICAL TECHNOLOGY, INC.MAL-0002-12018-09-18
00844685003761Malyugin Ring System 6.25mmMICROSURGICAL TECHNOLOGY, INC.MAL-0004-12018-09-18
00844685004577Medical Device Anterior Capsule RetractorMICROSURGICAL TECHNOLOGY, INC.MCR-0001-12018-09-16
00844685004874Medical Device Iris RetractorMICROSURGICAL TECHNOLOGY, INC.MIH-0001-12018-09-16
00844685006120Malyugin Ring System 2.0, 6.25mmMICROSURGICAL TECHNOLOGY, INC.MAL-1001-12018-09-18
00844685006137Malyugin Ring System 2.0, 7.0mmMICROSURGICAL TECHNOLOGY, INC.MAL-1002-12018-09-18
00844685006328MST Capsule Retractor, Chang ModificationMICROSURGICAL TECHNOLOGY, INC.MCR-0002-12018-09-16
10853480006126Fiber Optic Light GuideESCALON MEDICAL CORP.Iris Retractor, 20 ga2016-01-14
00856312006984Disposable Iris Retractor HookKATALYST SURGICAL LLCD4176-52016-08-08
00856312006991Disposable Iris Retractor HookKATALYST SURGICAL LLCD4176-22016-08-08