Needle, Ophthalmic Suturing
Ophthalmic · 21 CFR 886.4350
Recent MDR events
11 adverse event reports on file
- MICROSURGICAL INSTRUMENT, 23GA. SOFT TIP NEEDLEJul 3, 2013MalfunctionAlconmedical SafetyMW5030817
- STORZ ANTERIOR CHAMBER NEEDLE 27GAAug 18, 2011MalfunctionBausch & Lomb, Inc.1920664-2011-00108
- BD VISITECApr 12, 2010MalfunctionBd1664140
- BAUSCH AND LOMB STORZ ANTERIOR CHAMBER NEEDLEJun 5, 2009OtherBausch And Lomb StorzMW5011377
- HIGH SPEED VITRECTOMY CUTTERMar 26, 2007MalfunctionBausch & Lomb1920664-2007-00367
- 5192 FRONTALIS SUSPENSION SETDec 18, 1998MalfunctionBecton Dickinson1047439-1998-00002
- 5192 FRONTALIS SUSPENSION SETMay 6, 1998MalfunctionVisitec1047439-1998-00001
- VISITEC 5192Dec 29, 1997MalfunctionVisitec Co.1047439-1997-00001
- VISITEC 5192Nov 21, 1997InjuryVisitec134223
- GRIESHABERJun 6, 1997InjuryGrieshaber & CoMW1011412
Event type breakdown
Recalls
2 recall events for this product code
- Becton Dickinson and CompanyTerminatedDec 11, 2007
BD Visitec Nucleus Hydrodissector, .40 x 22 mm, (27Gx 7/8 in) , Sterile, Catalog #/REF #: 585155, Becton, Dickinson and Company, Waltham, MA 02452
No Fluid Flow or Restricted Fluid Flow: Nucleus Hydrodissector(s) were found to have reduced or no fluid flow.
Z-0453-2008 · View FDA record ↗ - Becton Dickinson and CompanyTerminatedDec 11, 2007
BD Visitec Nucleus Hydrodissector, .40 x 22 mm, (27 G x 7/8 in), Catalog #/REF #: 585793, Becton, Dickinson and Company, Waltham, MA 02452
No Fluid Flow or Restricted Fluid Flow: Nucleus Hydrodissector(s) were found to have reduced or no fluid flow
Z-0454-2008 · View FDA record ↗
Registered firms
81 firms currently registered for this product code
Beaver-visitec International, Ltd
BIDFORD-ON-AVON Warwickshire, GB
Integrated Orbital Implants, Inc.
SAN DIEGO, CA, US
Aurora Surgical, Llc
St Petersburg, FL, US
Medetz Surgical Instruments
Jupiter, FL, US
Akriti Ophthalmic Private Limited
Hyderabad Telangana, IN
Dufner Instrumente Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Hasa Optix
Brussels Brussels-Capital Region, BE
Strub Medical Gmbh & Co. Kg
NEUHAUSEN Baden-Wurttemberg, DE
Aurolab
MADURAI Tamil Nadu, IN
Aesculap, Inc.
CENTER VALLEY, PA, US
Millennium Surgical Corp
Schaumburg, IL, US
Vehu Medical Instrumente Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Bausch & Lomb Incorporated
Manchester, MO, US
Tontarra Medizintechnik Gmbh
WURMLINGEN Baden-Wurttemberg, DE
Katena Products, Inc.
Parsippany, NJ, US
Instrumed International Inc Dba Avalign German Specialty Instruments
SCHAUMBURG, IL, US
Duckworth & Kent, Ltd.
BALDOCK Hertfordshire, GB
Frank Mueller
Moessingen Baden-Wurttemberg, DE
Appasamy Associates Private Limited ( Thruvandar Koil)
Mannadipet Commune Puducherry, IN
Epsilon Eye Care Pvt., Ltd.
MUMBAI Maharashtra, IN
Crestpoint Management Ltd.
Crestwood, MO, US
Titan Surgical
KAZAN Tatarstan, RU
Microqore Medical Gmbh
Aach Baden-Wurttemberg, DE
Steris Deutschland Gmbh
Wurmlingen Baden-Wurttemberg, DE
Bis Mastermed
Kosice Kosicky, SK
510(k) clearances
2 clearances for this product code