Recall Register

Device recall: Product Name: ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number: 8065771540 Software Version: N/A…

Class II FDA enforcement event 94989. Recall start date: . Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

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.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Alcon Research LLC started this device recall on 15 Jul 2024. The firm address in the FDA record is in Fort Worth, TX. FDA put the recall in Class II. FDA event 94989 has 36 product records. The first FDA enforcement report date is 28 Aug 2024. The record gives the status Ongoing.

FDA enforcement reportThe 36 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Distribution

In the words of FDA.

Domestic: Nationwide Distribution Countries Affected: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Emirates, Finland,…

Recalling firm

Alcon Research LLC, Fort Worth, TX.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

36 product records in the event.

FDA event 94989: product records
Recall numberProductQuantityClassStatusReport date
Z-2645-2024Product Name: ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number: 8065771540 Software Version: N/A Product Description: Ophthalmic knife Component: N/A20,034 unitsClass IIOngoing28 Aug 2024
Z-2646-2024Product Name: 25GA VALVED ENTRY SYSTEM,3CT Model/Catalog Number: 8065751658 Software Version: N/A Product Description: Valved Trocar Entry System Component: N/A3,721 unitsClass IIOngoing28 Aug 2024
Z-2647-2024Product Name: 25+ TTL PLUS VPAK 20000CPM BWV Model/Catalog Number: 8065830077 Software Version: N/A Product Description: Standardized assemblage of components, which includes the valved trocar entry system, that interface with the CONSTELLATION Vision System. Component: N/A8,701 unitsClass IIOngoing28 Aug 2024
Z-2648-2024Product Name: Alcon Custom Pak Model/Catalog Number: Many Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various…384,851 unitsClass IIOngoing28 Aug 2024
Z-2649-2024Product Desc: Product Name: ClearCut S Safety Sideport Knife 1.2mm Dual Bevel Model/Catalog Number: 8065771541 Software Version: N/A Product Description: Ophthalmic knife Component: N/A5,039 unitsClass IIOngoing28 Aug 2024
Z-2650-2024Product Desc: Product Name: CLEARCUT SAFETY INTREPID SB,2.2 Model/Catalog Number: 8065772245 Software Version: N/A Product Description: Ophthalmic knife Component: N/A13,824 unitsClass IIOngoing28 Aug 2024
Z-2651-2024Product Desc: Product Name: CLEARCUT SAFETY INTREPID DB,2.2 Model/Catalog Number: 8065772265 Software Version: N/A Product Description: Ophthalmic knife Component: N/A1,152 unitsClass IIOngoing28 Aug 2024
Z-2652-2024Product Desc: Product Name: CLEARCUT SAFETY INTREPID SB,2.4 Model/Catalog Number: 8065772445 Software Version: N/A Product Description: Ophthalmic knife Component: N/A29,814 unitsClass IIOngoing28 Aug 2024
Z-2653-2024Product Desc: Product Name: CLEARCUT SAFETY INTREPID DB,2.4 Model/Catalog Number: 8065772465 Software Version: N/A Product Description: Ophthalmic knife Component: N/A1,932 unitsClass IIOngoing28 Aug 2024
Z-2654-2024Product Desc: Product Name: CLEARCUT SAFETY SLIT SB,2.75MMANG Model/Catalog Number: 8065772745 Software Version: N/A Product Description: Ophthalmic knife Component: N/A18,726 unitsClass IIOngoing28 Aug 2024
Z-2655-2024Product Desc: Product Name: A-OK 19G V-LANCE FULL HANDLE1.6MM SATIN Model/Catalog Number: 8065911901 Software Version: N/A Product Description: Ophthalmic knife Component: N/A14,216 unitsClass IIOngoing28 Aug 2024
Z-2656-2024Product Desc: Product Name: 20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N/A Product Description: Ophthalmic knife Component: N/A39,954 unitsClass IIOngoing28 Aug 2024
Z-2657-2024Product Desc: Product Name: ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065921541 Software Version: N/A Product Description: Ophthalmic knife Component: N/A469,173 unitsClass IIOngoing28 Aug 2024
Z-2658-2024Product Desc: Product Name: ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065982465 Software Version: N/A Product Description: Ophthalmic knife Component: N/A6,020 unitsClass IIOngoing28 Aug 2024
Z-2659-2024Product Desc: Product Name: CLEARCUT HP2 DB SLIT 3.0MM ANGCE Model/Catalog Number: 8065983065 Software Version: N/A Product Description: Ophthalmic knife Component: N/A2,520 unitsClass IIOngoing28 Aug 2024
Z-2660-2024Product Desc: Product Name: CLEARCUT HP2 DB SLIT 3.2MM ANGCE Model/Catalog Number: 8065983265 Software Version: N/A Product Description: Ophthalmic knife Component: N/A7,598 unitsClass IIOngoing28 Aug 2024
Z-2661-2024Product Desc: Product Name: A-OK SATINCRESCENT FULL HANDLE2.3MM ANG Model/Catalog Number: 8065990002 Software Version: N/A Product Description: Ophthalmic knife Component: N/A9,384 unitsClass IIOngoing28 Aug 2024
Z-2662-2024Product Desc: Product Name: CLEARCUT SB INTREPID 2.2 ANG Model/Catalog Number: 8065992245 Software Version: N/A Product Description: Ophthalmic knife Component: N/A11,916 unitsClass IIOngoing28 Aug 2024
Z-2663-2024Product Desc: Product Name: CLEARCUT SB INTREPID 2.2 ANG Model/Catalog Number: 8065992445 Software Version: N/A Product Description: Ophthalmic knife Component: N/A35,199 unitsClass IIOngoing28 Aug 2024
Z-2664-2024Product Desc: Product Name: CLEARCUT SB INTREPID 2.2 ANG Model/Catalog Number: 8065992561 Software Version: N/A Product Description: Ophthalmic knife Component: N/A3,419 unitsClass IIOngoing28 Aug 2024
Z-2665-2024Product Desc: Product Name: CLEARCUT SLIT FULL HANDLE2.6MM ANG DUAL Model/Catalog Number: 8065992647 Software Version: N/A Product Description: Ophthalmic knife Component: N/A5,487 unitsClass IIOngoing28 Aug 2024
Z-2666-2024Product Desc: Product Name: CLEARCUT SATINSLIT FULL HANDLE2.75MM AN Model/Catalog Number: 8065992745 Software Version: N/A Product Description: Ophthalmic knife Component: N/A145,248 unitsClass IIOngoing28 Aug 2024
Z-2667-2024Product Desc: Product Name: CLEARCUT SLIT FULL HANDLE2.75MM ANG DUA Model/Catalog Number: 8065992747 Software Version: N/A Product Description: Ophthalmic knife Component: N/A53,123 unitsClass IIOngoing28 Aug 2024
Z-2668-2024Product Desc: Product Name: A-OK SATINSLIT FULL HANDLE2.75MM ANG SG Model/Catalog Number: 8065992761 Software Version: N/A Product Description: Ophthalmic knife Component: N/A30,268 unitsClass IIOngoing28 Aug 2024
Z-2669-2024Product Desc: Product Name: CLEARCUT SATINSLIT FULL HANDLE3.0MM ANG Model/Catalog Number: 8065993045 Software Version: N/A Product Description: Ophthalmic knife Component: N/A11,676 unitsClass IIOngoing28 Aug 2024
Z-2670-2024Product Desc: Product Name: CLEARCUT SLIT FULL HANDLE3.0MM ANG DUAL Model/Catalog Number: 8065993047 Software Version: N/A Product Description: Ophthalmic knife Component: N/A15,222 unitsClass IIOngoing28 Aug 2024
Z-2671-2024Product Name: 25+ TOTALPLUS CP PAK 20K CPM BV .9 IU Model/Catalog Number: 8065000095 Software Version: N/A Component: N/A7,713 unitsClass IIOngoing28 Aug 2024
Z-2672-2024Product Name: 25+ TOTALPLUSr CP PAK 20K CPM BWV .9 IU Model/Catalog Number: 8065000093 Software Version: N/A Component: N/A1,061 unitsClass IIOngoing28 Aug 2024
Z-2673-2024Product Name: TOTAL PLUS,25+ 7.5CPM VALVE Model/Catalog Number: 8065751617 Software Version: N/A Component: N/A3,197 unitsClass IIOngoing28 Aug 2024
Z-2674-2024Product Name: TOTALPLUS,25+ 7.5CPM VALV WD6 Model/Catalog Number: 8065751618 Software Version: N/A Component: N/A324 unitsClass IIOngoing28 Aug 2024
Z-2675-2024Product Name: 25+ CMB PAK 7.5CPM,V,STD 0.9 Model/Catalog Number: 8065751767 Software Version: N/A Component: N/A3,791 unitsClass IIOngoing28 Aug 2024
Z-2676-2024Product Name: TOTAL PLUS,25+,10K VALVE STD Model/Catalog Number: 8065752437 Software Version: N/A Component: N/A7,108 unitsClass IIOngoing28 Aug 2024
Z-2677-2024Product Name: TOTAL PLUS,25+,10K VALVE WD Model/Catalog Number: 8065752438 Software Version: N/A Component: N/A4,766 unitsClass IIOngoing28 Aug 2024
Z-2678-2024Product Name: 25+ CMB PAK 10K CPM,V,STD 0.9 Model/Catalog Number: 8065752450 Software Version: N/A Component: N/A1,057 unitsClass IIOngoing28 Aug 2024
Z-2679-2024Product Name: 25+ CMB PAK 10K CPM,V,WA 0.9 Model/Catalog Number: 8065752451 Software Version: N/A Component: N/A4,481 unitsClass IIOngoing28 Aug 2024
Z-2680-2024Product Name: 25+TTLPL VPK 20000CPM BEV VAL Model/Catalog Number: 8065753106 Software Version: N/A Component: N/A6,972 unitsClass IIOngoing28 Aug 2024

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2024
970
Share of these events in Class II
87%
Product records in this event
36Median of the firm: 1
Events of the firm on the register
25

Other events of the firm

Other FDA enforcement events of Alcon Research LLC
InitiatedProduct (first record)TypeClassRecords
21 Apr 2026Systane, Lubricant Eye Gel, Night Gel, Sterile, 10g (0.35 oz), Processed in France for: Alcon Laboratiroes, Inc., Fort WDrugClass II2
24 Nov 2025Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Numbers: 9903-20, 17188-04, 19762-03, 19203-DeviceClass I1
30 Sep 2025Alcon PRECISION1 One-Day Contact Lenses, -2.25D.DeviceClass II1
15 Sep 2025CONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K, Description/REF: 25+ TOTALPLUS CP PAK 20K CPM BWV .9 IU/ 8065DeviceClass II1
5 Aug 2025Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles ModelDeviceClass II5
28 Apr 2025Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Vitrectomy Procedure Pak Model/Catalog NuDeviceClass II3
10 Feb 2025Alcon Custom Pak with Non-Latex Symbol, Pak: 12771-18, 18050-10, 18252-17, 12698-09, 15632-10, 3141-45, 12630-07, 18925-DeviceClass II1
18 Dec 2024Systane Lubricant Eye Drops, Ultra PF, Sterile, 25 Vials (0.7mL Each), Manufactured for: Alcon Laboratories, Inc. Forth DrugClass I1
13 Nov 2024Brand Name: Alcon Product Name: Monarch III D Delivery Cartridge Model/Catalog Number: 8065977763 Product Description: MDeviceClass II1
15 Oct 2024a) Alcon Custom-Pak CONSTELLATION 25G PLUS CHRISTIANA CARE HLTH SERV, # 15340-11, containing TUBING, SALEM SUMP, 14 FR; DeviceClass III1

Alcon Research LLC: all 25 events

Official channels

Cite this page

Recall Register. FDA enforcement event 94989. https://recallregister.com/fda/ii/94989/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA device enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
Newest FDA report date on the register
23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?
The FDA record gives this distribution: Domestic: Nationwide Distribution Countries Affected: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Emirates, Finland,…
What quantity of product is in FDA event 94989?
The event has 36 product records. The first record gives this quantity: 20,034 units
How did the recall start?
The FDA record says: Voluntary: Firm initiated
How many device recalls of 2024 have the same class?
87% of the 970 device events that started in 2024 are in Class II.