MSRClass II
Tubing, Replacement, Phacofragmentation Unit
Ophthalmic · 21 CFR 886.4150
MDR events10All time
Recalls0All time
Registered firms2Currently listed
510(k) clearances5All time
Recent MDR events
10 adverse event reports on file
- UNIVERSAL VISCOUS FLUID CONTROL PACKJul 20, 2023InjuryBausch + Lomb0001932402-2023-70002
- UNIVERSAL VISCOUS FLUID CONTROL PACKJan 4, 2023InjuryBausch + Lomb0001920664-2023-00002
- UNIVERSAL VISCOUS FLUID CONTROL PACKApr 8, 2020InjuryBausch + Lomb Inc0001932402-2020-00005
- BASIC VENTURI PHACO PACKJul 13, 2011MalfunctionBausch & Lomb, Inc.1920664-2011-00089
- ALCON TOTAL PLUS 23 GA VITRECTOMY PAKAug 20, 2009InjuryAlcon Laboratories, Inc.MW5012491
- ADVANCED FLOW SYSTEM PACKJun 30, 2009InjuryBausch & Lomb1920664-2009-00147
- VENTURI PHACO PACKApr 1, 2008InjuryBausch & Lomb1920664-2008-00407
- BASIC VENTURI PHACO PACKMar 20, 2006InjuryBausch & Lomb, Inc.1920664-2006-00015
- BASIC VENTURI PHACO PACKDec 22, 2005InjuryBausch & Lomb, Inc.1920664-2005-00131
- BASIC VENTURI PHACO PACKNov 3, 2005InjuryBausch & Lomb, Inc.1920664-2005-00113
Event type breakdown
Injury9
Malfunction1
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
2 firms currently registered for this product code
510(k) clearances
5 clearances for this product code
- Hurricane MedicalJan 4, 2000
K993361 · TUBING EXTENSION SET
- Med-Logics, Inc.Dec 18, 1998
K983448 · ML UNIVERSAL TUBING
- Surgin Surgical Instrumentation, Inc.Jul 9, 1998
K980849 · SURGIN KIT
- Storz Instrument Co.Jun 1, 1998
K980100 · STORZ DP4210 VENTURI ECONOMY ANTERIOR PACK AND DP5000 ASC DAYPACK
- Med-Logics, Inc.Sep 30, 1997
K972522 · ML-DISPOSABLE PAK