Trephine, Manual, Ophthalmic
Ophthalmic · 21 CFR 886.4350
Recent MDR events
23 adverse event reports on file
- TREPHINE BLADE, 9.25MM, STERILE, 1/EAApr 23, 2026MalfunctionBeaver-visitec International, Inc1211998-2026-00014
- HESSBURG BARRON VACUUM TREPHINENov 9, 2023MalfunctionJedmed Instrument Co.18100322
- IACCESS TRABECULAR TREPHINEOct 17, 2023InjuryGlaukos Corporation2032546-2023-00110
- IACCESS TRABECULAR TREPHINEAug 25, 2022InjuryGlaukos Corporation2032546-2022-00093
- TREPHINE VACUUM 8.0 MMOct 7, 2020MalfunctionJedmed Instrument Company10641440
- HESSBURG BARRONJan 28, 2013MalfunctionBarron Precision Instruments2935925
- IOWA PK PRESS PUNCHJun 1, 2011InjuryBausch & Lomb1920664-2011-00045
- CORONET VACUUM TREPHINEJul 8, 2010MalfunctionSurgical Specialties Corp. Dba Angiotech1766270
- CORNEAL TREPHINE BLADE 7.75MMFeb 25, 2010InjuryMedtronic Xomed, Inc.1045254-2010-00006
- CORNEAL TREPHINE BLADE 7.5MMFeb 25, 2010InjuryMedtronic Xomed, Inc.1045254-2010-00005
Event type breakdown
Recalls
1 recall events for this product code
Registered firms
125 firms currently registered for this product code
First Use Llc
LEXINGTON, KY, US
Rumex International Co.
Tampa, FL, US
Glaukos Corporation
San Clemente, CA, US
Akriti Ophthalmic Private Limited
Hyderabad Telangana, IN
Ambler Surgical, Llc
EXTON, PA, US
Beaver-visitec International, Inc.
Ciudad Juarez Chihuahua, MX
Synergy Health Sterilisation Uk Ltd
Berkshire Reading, GB
Jedmed Instrument Company
Saint Louis, MO, US
Med Saver, Inc.
PHOENIXVILLE, PA, US
Indo-german Surgical Corporation
Mumbai Maharashtra, IN
Mian Shahid Corp.
MUZAFFAR PUR, SIALKOT Punjab, PK
Falcon Surgical Co. (pvt.) Ltd.
Sialkot Punjab, PK
Millennium Surgical Corp
Schaumburg, IL, US
Rz Medizintechnik Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Asanus Medizintechnik Gmbh
NEUHAUSEN OBECK Baden-Wurttemberg, DE
Isomedix Operations Inc
EL PASO, TX, US
Bausch & Lomb Incorporated
Rochester, NY, US
Midwest Sterilization Corp.
JACKSON, MO, US
Bausch & Lomb Incorporated
Manchester, MO, US
Glorious Mercantile Corp. (pvt) Ltd.
SIALKOT Punjab, PK
Quality Concept (pvt) Ltd.
SIALKOT Punjab, PK
Steriservices
Bernay Eure, FR
Deroyal Industries, Inc.
POWELL, TN, US
Epsilon Eye Care Pvt., Ltd.
MUMBAI Maharashtra, IN
Madina Surgical Works
Sialkot Punjab, PK
510(k) clearances
12 clearances for this product code
- Stephens InstrumentsNov 1, 2002
K022843 · GAYHEART CORNEAL EXCISION DEVICE
- Intramed Laboratories, Inc.Jun 13, 1994
K931792 · ARTHROSCOPE
- Richmond Products, Inc.Oct 28, 1987
K873918 · HEAD & CHIN RESTS
- Precision Instruments, Inc.Jan 20, 1987
K864520 · BARRON ROTARY BLADE TREPHINE USING HESSBURG-BARRON
- Deknatel, Inc.Aug 11, 1986
K862524 · DEKNATEL (R) TREPHINE
- Storz Instrument Co.Jun 9, 1986
K861825 · CORNEAL TRANSPLANT TREPHINE DISPOSABLE BLADE
- Precision Instruments, Inc.Mar 25, 1986
K860648 · BARRON TWIN BLADE TREPHINE FOR EPPIKARATOPHAKIA
- Steinway Instrument Co., Inc.Jan 3, 1985
K843646 · STEINWAY MICRO-KERATO-TREPHINE