Public recall detail

Alcon Vitrectomy Products

2025-08-20

medium
Recall Safety notice
Quick summary

Quick summary: Alcon Vitrectomy Products. Date: 2025-08-20.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Alcon Vitrectomy Products. Date: 2025-08-20.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandAlcon Laboratories Inc.
ProductAlcon Vitrectomy Products
IssueMedical devices - Sterility
Recall classType II
IdentificationRA-77941

Affected products

ProductConstellation Vision System Viscous Fluid Control Pak With EnGauge RFID
Lot17DPRT
Model8065-7509-57
Serial number17DPRT
DescriptionConstellation Vision System Viscous Fluid Control Pak With EnGauge RFID
ProductConstellation Vision System Viscous Fluid Control Pak With EnGauge RFID
Lot17ERNK
Model8065-7509-57
Serial number17ERNK
DescriptionConstellation Vision System Viscous Fluid Control Pak With EnGauge RFID
ProductChandelier W/RFID
Lot17DPN7
Model8065751577
Serial number17DPN7
DescriptionChandelier W/RFID
ProductChandelier W/RFID
Lot17DPN8
Model8065751577
Serial number17DPN8
DescriptionChandelier W/RFID
ProductEndoillumination Probes
Lot17E0TX
Model8065750972
Serial number17E0TX
DescriptionEndoillumination Probes
ProductEndoillumination Probes
Lot17C359
Model8065751441
Serial number17C359
DescriptionEndoillumination Probes
ProductEndoillumination Probes
Lot17C6U5
Model8065751441
Serial number17C6U5
DescriptionEndoillumination Probes

Issue

Alcon is conducting this voluntary medical device field safety correction of impacted standalone vitrectomy consumables, as there is potential for some pouches within impacted lots to have an incomplete seal. While the incomplete seal is visibly noticeable within the pouch, due to the risk that the sterile barrier may be compromised, Alcon is conducting a recall. Should a non-sterile product be used during surgery, post-operative infection may result requiring medical and/or surgical intervention. To date, there have been no reported complaints for this issue from customers for the product in scope. Recall start date: August 11, 2025

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Ophthalmology
CompaniesAlcon Laboratories Inc. 6201 South Freeway, Fort Worth, Texas, United States, 76134-2099
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-77941
Background{}
CompaniesAlcon Laboratories Inc. 6201 South Freeway, Fort Worth, Texas, United States, 76134-2099
AudiencesHealthcare
Source updated2025-08-20

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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