Medical device licence · 113618 · Class 3
UNITY VITREORETINAL CATARACT SYSTEM (VCS)
Yes: licensed in Canada
Licence status Issued (active); first licensed July 3, 2025. It is in Health Canada’s list of active licences.
- Licence number
- 113618
- Licence holder
- Alcon Laboratories Inc.Orlando, FL, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- July 3, 2025
- Devices covered
- 47
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- 20GA FRAG PACK
- 22GA OZIL FRAG PACK
- 23GA ANTERIOR VITRECTOMY KIT 7.5K
- 23GA ULTRAVIT 10K PROBE
- 23GA UNITY TOTALPLUS COMBINED PROCEDURE PACK
- 23GA UNITY TOTALPLUS COMBINED PROCEDURE VALUE PACK, CVS ES ULTRAVIT 10K, ULTRA, TIPLESS
- 23GA UNITY TOTALPLUS POSTERIOR PACK, CVS ES ULTRAVIT 10K, STRAIGHT
- 23GA UNITY TOTALPLUS POSTERIOR VALUE PACK, CVS ES ULTRAVIT 10K
- 25+ ANTERIOR VITRECTOMY KIT 7.5K
- 25+ HYPERVIT 30K PROBE
- 25+ SHORT ULTRAVIT 10K PROBE
- 25+ ULTRAVIT 10K PROBE
- 25+ UNITY TOTALPLUS COMBINED PROCEDURE PACK
- 25+ UNITY TOTALPLUS COMBINED PROCEDURE VALUE PACK
- 25+ UNITY TOTALPLUS POSTERIOR PACK
- 25+ UNITY TOTALPLUS POSTERIOR VALUE PACK
- 25GA HIGH PERFORMANCE VALVED ENTRY SYSTEM
- 25GA HIGH PERFORMANCE VALVED SHORT ENTRY SYSTEM
- 25GA INFUSION CANNULA
- 25GA LONG ULTRAVIT 10K PROBE
- 25GA SHORT INFUSION CANNULA
- 25GA TETRASPOT MULTISPOT LASER PROBE
- 27+ ULTRAVIT 10K PROBE
- 27+ UNITY TOTALPLUS COMBINED PROCEDURE PACK
- 27+ UNITY TOTALPLUS COMBINED PROCEDURE VALUE PACK
- 27+ UNITY TOTALPLUS POSTERIOR PACK
- 27+ UNITY TOTALPLUS POSTERIOR VALUE PACK
- 27+DS HYPERVIT 30K PROBE
- 27+DS STRAIGHT LIGHT PROBE
- 27+DS WIDE ANGLE LIGHT PROBE
- 27GA CHANDELIER
- 27GA HIGH PERFORMANCE VALVED ENTRY SYSTEM
- 27GA HIGH PERFORMANCE VALVED SHORT ENTRY SYSTEM
- 27GA ILLUMINATED FLEXIBLE CURVED LASER PROBE
- 27GA INFUSION CANNULA
- 27GA SHORT INFUSION CANNULA
- 27GA TETRASPOT MULTISPOT LASER PROBE
- HIGH PERFORMANCE VISCOUS FLUID CONTROL PACK
- LASER KIT
- UNITY 4 BUTTON FOOT CONTROLLER
- UNITY 4D PHACO HANDPIECE
- UNITY CATARACT FMS PACK
- UNITY LASER FOOT CONTROLLER
- UNITY OZIL FRAGMENTATION HANDPIECE
- UNITY REMOTE CONTROL
- UNITY VCS 6 BUTTON FOOT CONTROLLER
- UNITY VCS SYSTEM
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.