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Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT recallZ-2679-2024 · Alcon Research LLC · initiated Jul 15, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Alcon Research LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

FDA root cause category: Process control

What the company is doing

On July 15, 2024, URGENT: MEDICAL DEVICE FIELD CORRECTION letters were sent to customers. Actions to be taken by the Customer / User: Our records indicate that you have received affected sterile standalone knives/trocar entry systems, Vitrectomy/Combined Procedure Pak, or an Alcon Custom Pak with an affected knives/trocar entry system lot number. 1. If you received sterile standalone knives or trocar entry system, we are asking that you dispose of the affected ophthalmic knife/trocar entry system and use a replacement. Alcon is sending sufficient replacement quantities to cover your estimated remaining impacted inventory. 2. If you received a Vitrectomy/Combined Procedure Pak with affected trocar entry system lot numbers, we are asking that, upon opening your Vitrectomy/Combined Procedure Pak for surgical use, you remove and dispose of the affected trocar entry system and use a replacement trocar entry system. Alcon is sending sufficient replacement quantities to cover your estimated remaining impacted inventory. 3. If you received an Alcon Custom Pak with affected knife or trocar entry system lot numbers, we are asking that, upon opening your Custom Pak for surgical use, you remove and dispose of the affected knife or trocar entry system contained within your specific lot(s) of Alcon Custom Pak and use a replacement knife or trocar entry system. If you have a Custom Pak lot listed in Appendix 1, then one or two of the knives/trocar entry systems in your Custom Pak may be affected by the field correction. Please refer to the impacted lot list in Appendix 1 to ensure that the appropriate knife/trocar entry system is removed. Alcon is sending replacement quantities of knives and/or trocar entry system to cover your estimated remaining impacted inventory, and any future shipments of impacted Custom Pak lots. NOTE: Alcon surgical products are sterile and should not be opened before surgery. The remaining components of the Alcon Custom Pak are unaffected by thi

Recall details

Recall number
Z-2679-2024
Status
Open, Classified
Initiated by the company
Jul 15, 2024
Posted by the FDA
Aug 16, 2024
Recalling firm
Alcon Research LLC
Quantity
4,481 units
Product code
HQC
Distribution
Domestic: Nationwide Distribution Countries Affected: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Emirates, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Japan, Korea, Kosovo, Luxemburg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UK, Ukraine, Uruguay, USA

Product description

Product Name: 25+ CMB PAK 10K CPM,V,WA 0.9 Model/Catalog Number: 8065752451 Software Version: N/A Component: N/A

Code information (models, lots, serial numbers)

Model/Catalog Number: 8065752451; UDI-DI: 380657524518; Lot numbers: 16AUN4, 16AUN3, 16C9PX, 16C9PY, 16C9R0.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 94989).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page