Health product recall

Constellation® UltraVit® and HyperVit® Vitrectomy Probe

Last updated

Summary

Product
Constellation® UltraVit® and HyperVit® Vitrectomy Probe
Issue
Medical devices - Labelling and packaging
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalogue number
Probe, Posterior Vit More than 10 numbers, contact manufacturer. 8065752413
Probe, Posterior Vit More than 10 numbers, contact manufacturer. 8065752415
Probe, Posterior Vit More than 10 numbers, contact manufacturer. 8065752417
Constellation® Vision System Total Plus Vitrectomy Pak More than 10 numbers, contact manufacturer. 8065000093
Constellation® Vision System Total Plus Vitrectomy Pak More than 10 numbers, contact manufacturer. 8065752438
Constellation® Vision System Total Plus Vitrectomy Pak More than 10 numbers, contact manufacturer. 8065000095
Constellation® Vision System Total Plus Vitrectomy Pak More than 10 numbers, contact manufacturer. 8065752437
Constellation® Vision System Total Plus Vitrectomy Pak More than 10 numbers, contact manufacturer. 8065752439
Constellation® Vision System Total Plus Vitrectomy Pak More than 10 numbers, contact manufacturer. 8065753109
Constellation® Vision System Total Plus Vitrectomy Pak More than 10 numbers, contact manufacturer. 8065752435
Constellation® Vision System Total Plus Vitrectomy Pak More than 10 numbers, contact manufacturer. 8065830077
Constellation® Vision System Total Plus Vitrectomy Pak More than 10 numbers, contact manufacturer. 8065753106
Constellation® Vision System Total Plus Vitrectomy Pak More than 10 numbers, contact manufacturer. 8065752436
Constellation® Vision System Total Plus Vitrectomy Pak More than 10 numbers, contact manufacturer. 8065000096
Constellation® System, Total Plus Combined Procedure Pak More than 10 numbers, contact manufacturer. 8065752449
Constellation® System, Total Plus Combined Procedure Pak More than 10 numbers, contact manufacturer. 8065752450
Constellation® System, Total Plus Combined Procedure Pak More than 10 numbers, contact manufacturer. 8065752448
HyperVit® Bevel Vitrectomy Probe More than 10 numbers, contact manufacturer. 8065830026
HyperVit® Bevel Vitrectomy Probe More than 10 numbers, contact manufacturer. 8065830027

Issue

Alcon is conducting a voluntary medical device field safety corrective action for specific models of Constellation® UltraVit® (10k) and HyperVit® (20k) vitrectomy probe as there is potential for probes to unexpectedly fail to actuate and cut during use.  There is a remote chance that an adverse event may occur if a probe unexpectedly fails to actuate and cut during surgery. Depending on the position of the cutter when the issue occurs and the amount of suction pressure applied by the probe, there is a potential for increased traction on the vitreous and/or retina that could lead to holes/tears.

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Ophthalmology
Companies

Alcon Laboratories Inc.

6201 South Freeway, Fort Worth, Texas, United States, 76134-2099

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-78133

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