Hook, Ophthalmic
Ophthalmic · 21 CFR 886.4350
Recent MDR events
109 adverse event reports on file
- MILOOP ®Feb 24, 2026InjuryCarl Zeiss Meditec Ag (oberkochen)9615010-2026-00002
- MILLENNIUM SURGICALJan 30, 2026Malfunction1421101-2026-00001
- KOCH SPATULA AND NAGAHARA CHOPPER DEDec 10, 2025MalfunctionInstrumed Gmbh Dba Avalign German Specialty InstrumentsMW5180236
- BVI GOVAN MANIPULATORApr 30, 2025InjuryBeaver-visitec International, Ltd3002808441-2025-00003
- BVI GOVAN MANIPULATORApr 30, 2025InjuryBeaver-visitec International, Ltd1211998-2025-00003
- GRIESHABER DELAMINATION SPATULA DSPApr 1, 2025InjuryAlcon Grieshaber Ag3003398873-2025-00250
- GRIESHABER DELAMINATION SPATULA DSPApr 1, 2025InjuryAlcon Grieshaber Ag3003398873-2025-00252
- GRIESHABER PIC DSPMar 27, 2025InjuryAlcon Grieshaber Ag3003398873-2025-00245
- GRIESHABER DELAMINATION SPATULA DSPMar 27, 2025InjuryAlcon Grieshaber Ag3003398873-2025-00244
- GRIESHABER DELAMINATION SPATULA DSPMar 17, 2025InjuryAlcon Grieshaber Ag3003398873-2025-00221
Event type breakdown
Recalls
4 recall events for this product code
- Vortex Surgical Inc.Open, ClassifiedFeb 4, 2026
Tecfen Retractable Membrane Polisher, QTPR1267-23
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
Z-1251-2026 · View FDA record ↗ - Vortex Surgical Inc.Open, ClassifiedFeb 4, 2026
Rumex Disposable Diamond Dusted ILM Elevator, 12-7523
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
Z-1253-2026 · View FDA record ↗ - Sklar InstrumentsOpen, ClassifiedJan 16, 2025
ECONO STERILE medical procedure kits labeled as:
Reports of various packaging issues that may result in a breach of the sterile barrier.
Z-0951-2025 · View FDA record ↗ - Carl Zeiss Meditec AGOpen, ClassifiedUnknown
ZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000. Used during cataract surgery.
High friction of the slider can cause the device to stick, or not move as intended.
Z-1007-2022 · View FDA record ↗
Registered firms
190 firms currently registered for this product code
Anodyne Surgical
O Fallon, MO, US
Kls Martin Se & Co. Kg
Fridingen Baden-Wurttemberg, DE
Asanus Medizintechnik Gmbh
NEUHAUSEN OBECK Baden-Wurttemberg, DE
Addn Solutions Gmbh & Co. Kg
Wurmlingen Baden-Wurttemberg, DE
Instrumentarium Surgical Corp., Inc.
TERREBONNE Quebec, CA
Elmed, Inc.
Glendale Heights, IL, US
Surgix Medical Llc
Spring, TX, US
Shamsi Surgical
Sialkot Punjab, PK
Oertel Medical Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Microsurgical Technology, Inc.
Redmond, WA, US
Steriservices
Bernay Eure, FR
Wexler Surgical, Inc.
HOUSTON, TX, US
Stephens Instruments, Inc
LEXINGTON, KY, US
Bgs Beta-gamma-service Gmbh & Co Kg
Wiehl North Rhine-Westphalia, DE
Coastline De Mexico Sa De Cv
Tijuana Baja California, MX
Fci Sud
MAPOU LECLEZIO GOODLANDS Riviere du Rempart, MU
Inka Surgical Instruments
Jandakot Western Australia, AU
Steris Corporation
Saint Louis, MO, US
A1 Medical Gmbh
Tuttlingen Baden-Wurttemberg, DE
Wildmedical Gmbh
Tuttlingen Baden-Wurttemberg, DE
Sterigenics U.s., Llc
Haw River, NC, US
Kls-martin L.p.
Jacksonville, FL, US
Bis Mastermed
Kosice Kosicky, SK
Surgical Instrument Manufacturers, Llc
FENTON, MO, US
Speedway
India Delhi, IN
510(k) clearances
10 clearances for this product code
- Ophtec, USAApr 17, 2003
K030471 · OPHTEC ENCLAVATION NEEDLE
- Stephens InstrumentsNov 1, 2002
K022842 · STEPHENS DISPOSABLE HOOKS
- Advanced Surgical Products, Inc.Apr 13, 1988
K874991 · PRISMA DISPOSABLE IRRIGATING IRIS HOOK
- Look, Inc.Feb 20, 1987
K870440 · LOOK LENS LOOPS
- Eye-Ko, Inc.Dec 29, 1986
K864292 · DISPOSAL SURGICAL INSTRUMENTS FOR OPHTHALMOLOGY
- Keeler Instruments, Inc.Oct 31, 1986
K863988 · THORTON TITANIUM HOOK ANGLED RIGHT
- Edward Weck, Inc.Jul 28, 1980
K801469 · BONN MICRO IRIS HOOK (NON-STERILE) #7613
- Edward Weck, Inc.Oct 4, 1979
K791985 · HOOKS #'S 7600,7602,7603,7616