Alcon Research LLC: Product Name: TOTAL PLUS,25+,10K VALVE STD Model/Catalog Number: 8065752437 Software Version: N/A Component: N/A

Recall number

Z-2676-2024

Recalling firm

Alcon Research LLC

Product

Product Name: TOTAL PLUS,25+,10K VALVE STD Model/Catalog Number: 8065752437 Software Version: N/A Component: N/A

Status

Open, Classified

Initiated

2024-07-15

Posted

2024-08-16

Terminated

not on file

Reason

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.

Root cause

Process control

Action

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

Quantity

7,108 units

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

Lot, serial or model codes

Model/Catalog Number: 8065752437; UDI-DI: 380657524372; Lot numbers: 16AUM5, 16C9RE, 16DDFN, 16HE6A, 16HYDP, 16HYDR, 16HYDT.

510(k) numbers

not on file

PMA numbers

not on file

Product code

HQC

Firm FEI

1610287

Firm city

Fort Worth

Firm state

TX

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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