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25+ Total Plus Pak (Alcon) – Sharpness Complaint (2024)

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.

Moderate

FDAJul 15, 2024Nationwide• Alcon Research LLC Aspex Facility

Product Name: ClearCut S Safety Sideport Knife 1.0mm Dual... (Alcon Research LLC Aspex Facility) – laceration hazard (2024)

Laceration Risk

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.

Moderate

FDAJul 15, 2024Nationwide

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25+ Total Plus Pak (Alcon) – Sharpness Complaint (2024)

Product Name: ClearCut S Safety Sideport Knife 1.0mm Dual... (Alcon Research LLC Aspex Facility) – laceration hazard (2024)

Product Name: 25+ TTL PLUS VPAK 20000CPM BWV Model/Catalo... (Alcon Research LLC Aspex Facility) – laceration hazard (2024)

25+ Total Plus Pak (Alcon) – Sharpness Complaint (2024)

A-OK 19G V-Lance (Alcon) – Sharpness Complaint (2024)

25+ CMB Pak (Alcon) – Sharpness Complaint (2024)

TiBrid Fusion Device (Unknown) – Instrument Failure (2024)

Alcon Custom Pak (Alcon) – Sharpness Complaint (2024)

Collagen Joint Support (Quantum Fulfillment) – Undeclared Fish (2024)

Aisys (Datex-Ohmeda) – Gas Outlet Risk (2024)

Ion Endoluminal System (Intuitive Surgical) – Arm Screw Risk (2024)

Avance CS2 (Datex-Ohmeda) – Gas Outlet Risk (2024)

ACGO Conversion Kit (Datex-Ohmeda) – Gas Outlet Risk (2024)

DxI 9000 Analyzer (Beckman Coulter) – Electric Short Risk (2024)

Aespire 100 (Datex-Ohmeda) – Gas Outlet Risk (2024)

Amingo (Datex-Ohmeda) – Gas Outlet Risk (2024)

Proteus XR/a X-Ray System (GE Healthcare) – Missing Manual (2024)

Aespire 7100 (Datex-Ohmeda) – Gas Outlet Risk (2024)

NavaClick Syringe (Lineage Biomedical) – Incorrect GTIN (2024)

Gold Hard Steel Plus (Supercore) – Undeclared Drugs (2024)