Unit, Phacofragmentation
Ophthalmic · 21 CFR 886.4670
Recent MDR events
41,218 adverse event reports on file
- UNITY Vision System, Accessory, Active Sentry HandpieceJul 31, 2026InjuryAlcon Research, Llc - Irvine Technology Center2028159-2026-01174
- UNITY Vision System, Accessory, Active Sentry HandpieceJul 31, 2026InjuryAlcon Research, Llc - Irvine Technology Center2028159-2026-01173
- UNITY Vision System, Accessory, Active Sentry HandpieceJul 31, 2026InjuryAlcon Research, Llc - Irvine Technology Center2028159-2026-01175
- UNITY Vision System, Accessory, Active Sentry HandpieceJul 31, 2026InjuryAlcon Research, Llc - Irvine Technology Center2028159-2026-01179
- UNITY Vision System, Accessory, Active Sentry HandpieceJul 31, 2026InjuryAlcon Research, Llc - Irvine Technology Center2028159-2026-01177
- UNITY Vision System, Accessory, Active Sentry HandpieceJul 31, 2026InjuryAlcon Research, Llc - Irvine Technology Center2028159-2026-01178
- UNITY VCS ConsoleJul 31, 2026InjuryAlcon Research, Llc - Irvine Technology Center2028159-2026-01176
- UNITY VCS ConsoleJul 31, 2026InjuryAlcon Research, Llc - Irvine Technology Center2028159-2026-01180
- UNITY Vision System, Accessory, Active Sentry HandpieceJul 31, 2026InjuryAlcon Research, Llc - Irvine Technology Center2028159-2026-01184
- UNITY CS ConsoleJul 31, 2026MalfunctionAlcon Research, Llc - Irvine Technology Center2028159-2026-01181
Event type breakdown
Most-reported manufacturers
Recalls
74 recall events for this product code
- Alcon Research LLCOpen, ClassifiedOct 24, 2025
Brand Name: Alcon Laboratories, Inc.
Due to incomplete seals in the pouch which provide the sterile barrier.
Z-0305-2026 · View FDA record ↗ - Alcon Research LLCOpen, ClassifiedJul 10, 2025
Brand Name: Alcon Laboratories, Inc.
Due to the potential that some units within specific lots were damaged during the manufacturing process. The area of damage is within the same area of the lidding. While the damage in the lidding is visibly noticeable, due to risk of sterility being compromised.
Z-2109-2025 · View FDA record ↗ - Alcon Research LLCOpen, ClassifiedAug 16, 2024
Product Name: 25GA VALVED ENTRY SYSTEM,3CT
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.
Z-2646-2024 · View FDA record ↗ - Alcon Research LLCOpen, ClassifiedAug 16, 2024
Product Name: 25+ TTL PLUS VPAK 20000CPM BWV
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.
Z-2647-2024 · View FDA record ↗ - Alcon Research LLCOpen, ClassifiedAug 16, 2024
Product Name: 25+ TOTALPLUS CP PAK 20K CPM BV .9 IU
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.
Z-2671-2024 · View FDA record ↗ - Alcon Research LLCOpen, ClassifiedAug 16, 2024
Product Name: 25+ TOTALPLUSr CP PAK 20K CPM BWV .9 IU
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.
Z-2672-2024 · View FDA record ↗ - Alcon Research LLCOpen, ClassifiedAug 16, 2024
Product Name: TOTAL PLUS,25+ 7.5CPM VALVE
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.
Z-2673-2024 · View FDA record ↗ - Alcon Research LLCOpen, ClassifiedAug 16, 2024
Product Name: TOTALPLUS,25+ 7.5CPM VALV WD6
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.
Z-2674-2024 · View FDA record ↗ - Alcon Research LLCOpen, ClassifiedAug 16, 2024
Product Name: 25+ CMB PAK 7.5CPM,V,STD 0.9
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.
Z-2675-2024 · View FDA record ↗ - Alcon Research LLCOpen, ClassifiedAug 16, 2024
Product Name: TOTAL PLUS,25+,10K VALVE STD
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.
Z-2676-2024 · View FDA record ↗
Registered firms
304 firms currently registered for this product code
Isomedix Operations Inc.
CHESTER, NY, US
Bausch & Lomb Incorporated
Rochester, NY, US
This Ag
Heerbrugg Sankt Gallen, CH
Sterigenics Us Llc
Fort Worth, TX, US
Sterigenics Belgium Petit Rechain S.a.
Verviers Liege, BE
Alcon Grieshaber Ag
Neuhausen Schaffhausen, CH
Carl Zeiss Meditec Ag (oberkochen)
OBERKOCHEN Baden-Wurttemberg, DE
Providence Enterprise Limited
Shenzhen Guangdong, CN
Sterigenics U.s., Llc
Haw River, NC, US
Isomedix Operations Inc
GROVEPORT, OH, US
Bgs Beta-gamma-service Gmbh & Co Kg
Wiehl North Rhine-Westphalia, DE
Carl Zeiss Meditec Cataract Technology Inc
Reno, NV, US
Zevex, Inc.
Salt Lake City, UT, US
Coastline De Mexico Sa De Cv
Tijuana Baja California, MX
Bausch & Lomb Incorporated
Manchester, MO, US
Bausch & Lomb Incorporated
Saint Louis, MO, US
Midwest Sterilization Corp.
JACKSON, MO, US
Toyo Medical Co.
Doral, FL, US
510(k) clearances
316 clearances for this product code
- Bausch and LombMay 15, 2026
K261264 · Stellaris Elite vision enhancement system; Posterior and Combined Procedure Pack(s): 23 ga. Posterior Elite Pack (SE5423); 23 ga. Bi-Blade Vitreous Cutter Posterior Stellaris Elite Pack (SE5423B); 25 ga. Posterior Elite Pack (SE5425); 25 ga. Bi-Blade Vitreous Cutter Posterior Stellaris Elite Pack (SE5425B); 27 ga. Bi-Blade Vitreous Cutter Posterior Stellaris Elite Pack (SE5427B); 23 ga. Bi-Blade+ Vitreous Cutter Posterior Stellaris Elite Pack (SE5423BB+); 25 ga. Bi-Blade+
- Bausch and Lomb, IncorporatedMar 25, 2026
K252052 · Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)
- This AGNov 14, 2025
K250501 · System Sophi
- Carl Zeiss Meditec Cataract Technology, Inc.Aug 8, 2025
K243395 · MICOR 700 with Auto I/A
- Carl Zeiss Meditec Cataract Technology, Inc.Jun 11, 2025
K242801 · MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185)
- Bausch and Lomb, IncorporatedJul 26, 2024
K240169 · Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)
- Oertli Instrumente AGJun 27, 2024
K233398 · Faros Surgical System
- Alcon Laboratories, Inc.Jun 21, 2024
K233876 · UNITY VCS (8065000296); UNITY CS (8065000297)