Marker, Ocular
Ophthalmic · 21 CFR 886.4570
Recent MDR events
18 adverse event reports on file
- VERION DIGITAL MARKER MJul 22, 2026MalfunctionWavelight Gmbh (agps)3010300699-2026-00008
- VERION DIGITAL MARKER MJun 3, 2026MalfunctionWavelight Gmbh (agps)3010300699-2026-00007
- VERION DIGITAL MARKER MMay 12, 2026MalfunctionWavelight Gmbh (agps)3010300699-2026-00006
- VERION DIGITAL MARKER MMay 11, 2026InjuryWavelight Gmbh (agps)3010300699-2026-00005
- VERION DIGITAL MARKER MMay 1, 2026InjuryWavelight Gmbh (agps)3010300699-2026-00004
- VERION DIGITAL MARKER LApr 3, 2026MalfunctionWavelight Gmbh (agps)3010300699-2026-00003
- VERION DIGITAL MARKER MFeb 5, 2026InjuryWavelight Gmbh (agps)3010300699-2026-00002
- VERION DIGITAL MARKER MJan 7, 2026MalfunctionWavelight Gmbh (agps)3010300699-2026-00001
- VERION DIGITAL MARKER MDec 15, 2025MalfunctionWavelight Gmbh (agps)3010300699-2025-00011
- VERION DIGITAL MARKER MNov 16, 2025MalfunctionWavelight Gmbh (agps)3010300699-2025-00010
Event type breakdown
Most-reported manufacturers
Recalls
6 recall events for this product code
- Aspen Surgical Products, Inc.TerminatedFeb 16, 2011
Oasis Corneal Marking Pad, REF 0441, Rx only, Sterile. For use in ophthalmic surgery.
Fragments from the pad may disengage and stick to the instrument. The condition could cause fragments to come into contact with the intact cornea prior to surgery.
Z-1335-2011 · View FDA record ↗ - Aspen Surgical Products, Inc.TerminatedFeb 16, 2011
Aspen Surgical, Corneal Marking Pad, Gentian Violet Ink, REF 40490, Rx only, Sterile. For use in ophthalmic surgery.
Fragments from the pad may disengage and stick to the instrument. The condition could cause fragments to come into contact with the intact cornea prior to surgery.
Z-1336-2011 · View FDA record ↗ - Aspen Surgical Products, Inc.TerminatedFeb 16, 2011
Eagle Labs Corneal Marking Pad, Gentian Violet, REF 63-001, Sterile. For use in ophthalmic surgery.
Fragments from the pad may disengage and stick to the instrument. The condition could cause fragments to come into contact with the intact cornea prior to surgery.
Z-1337-2011 · View FDA record ↗ - Aspen Surgical Products, Inc.TerminatedFeb 16, 2011
CYNACON OcuSOFT LASIK Marker Pads, REF 750-093, Rx Only, Sterile. For use in ophthalmic surgery.
Fragments from the pad may disengage and stick to the instrument. The condition could cause fragments to come into contact with the intact cornea prior to surgery.
Z-1338-2011 · View FDA record ↗ - Aspen Surgical Products, Inc.TerminatedFeb 16, 2011
Viscot Medical, LLC., Vismark Gentian Violet Marking Pad, Rx Only, Sterile, REF GV1200S. For use in ophthalmic surgery.
Fragments from the pad may disengage and stick to the instrument. The condition could cause fragments to come into contact with the intact cornea prior to surgery.
Z-1339-2011 · View FDA record ↗ - Aspen Surgical Products, Inc.TerminatedFeb 16, 2011
Walcott Rx Products, Surgical Division, Corneal Marking Pad, REF RX40490, Sterile. For use in ophthalmic surgery.
Fragments from the pad may disengage and stick to the instrument. The condition could cause fragments to come into contact with the intact cornea prior to surgery.
Z-1340-2011 · View FDA record ↗
Registered firms
99 firms currently registered for this product code
Phoenix Instruments, Inc.
Lisle, IL, US
Beaver-visitec International, Inc.
Ciudad Juarez Chihuahua, MX
Novo Surgical, Inc.
Westmont, IL, US
Belle Healthcare Technology Co., Ltd.
Suzhou Jiangsu, CN
Fetzer Medical Gmbh & Co.kg
Tuttlingen Baden-Wurttemberg, DE
Grupo American Industries, S.a. De C.v
Ciudad Juarez Chihuahua, MX
Microsurgical Technology, Inc.
Redmond, WA, US
Asol Co.,ltd
huaian Jiangsu, CN
Steriservices
Bernay Eure, FR
Hayden Medical Inc
Valencia, CA, US
Carl Zeiss Meditec Ag (jena)
JENA Thuringia, DE
Asanus Medizintechnik Gmbh
NEUHAUSEN OBECK Baden-Wurttemberg, DE
Medetz Surgical Instruments
Jupiter, FL, US
Accutome, Inc.
Malvern, PA, US
Carl Teufel Gmbh & Co. Kg
LIPTINGEN Baden-Wurttemberg, DE
Geuder Ag
HEIDELBERG Baden-Wurttemberg, DE
Iscon Surgicals, Ltd.
JODHPUR Rajasthan, IN
Rz Medizintechnik Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Bausch & Lomb Incorporated
Rochester, NY, US
Ambler Surgical, Llc
EXTON, PA, US
Carl Zeiss Meditec Ag (munich)
Muenchen Bavaria, DE
Carl Zeiss Meditec Ag (oberkochen)
OBERKOCHEN Baden-Wurttemberg, DE
Malosa Medical Instruments (changshu) Limited
Changshu Jiangsu, CN
Kazan Medical Instruments Plant Joint Stock Compan
KAZAN Tatarstan, RU
Med-logics, Inc.
Athens, TX, US
510(k) clearances
5 clearances for this product code
- Refractec, Inc.Mar 3, 2006
K053475 · OPTIPOINT CORNEAL MARKER, MODEL VPT-OPT-450
- Chiron Vision Corp.Aug 29, 1994
K925606 · OPTICAL ZONE/HEXAGONAL/ASTIGMATISM/RADIAL MARKERS
- Innomed Corp.Sep 4, 1987
K872747 · LASER CENTERING DEVICE
- Myocure, Inc.Oct 20, 1986
K863663 · OPHTHALMIC SURGICAL OCULAR MARKERS
- CooperVision, Inc.May 14, 1986
K861535 · OPTICAL MARKERS/FIXATION RING/CANNU & IRRIGA CANNU