MAUDE Adverse Event Report: ALCON RESEARCH, LLC - ALCON PRECISION DEVICE CENTURION VISION SYSTEM, HANDPIECE TIP; UNIT, PHACOFRAGMENTATION

Catalog Number 8065752066

Device Problems Complete Blockage (1094); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Corneal Ulcer (1796); Blurred Vision (2137); Eye Burn (2523)

Event Date 02/25/2022

Event Type  Injury  

Manufacturer Narrative

Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: 2022-12308.

Event Description

A pharmacist reported the patient experienced a corneal burn and leakage at the incision site during a surgery.The product was replaced and the procedure was completed.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Event Description

Additional information received from the company representative that indicated monofilament suture were made over the initial incision.There was an occlusion problem during the surgery.The current condition of the patient is not resolved, thermal burn resulted in corneal opacity the induced corneal opacity resulted in = 2 line decrease in best corrected visual acuity (bcva) compared to baseline, corneal ectasia, neurotrophic corneal ulcer and major astigmatism.The patient was treated with healing eye drops and antibiotics.

Manufacturer Narrative

A sample was not received at the manufacturing site; therefore, the condition of the product could not be verified.A review of the device history record traceable to the reported lot number, indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.A sample was not received at the manufacturing site and the device history record review of the lot number provided indicated the product was processed and released according to the product¿s acceptable criteria, therefore; the root cause for the customer complaint issue cannot be determined.The exact root cause for this complaint is unknown; therefore, specific action with regards to this complaint cannot be taken.All phacoemulsification tips are 100% visually inspected by trained operators using 30x magnification during the manufacturing process.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No adverse trends have been observed associated with the reported product and event.No further actions are required.The manufacturer internal reference number is:(b)(4).

• Brand Name: CENTURION VISION SYSTEM, HANDPIECE TIP
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LLC - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• Manufacturer (Section G): ALCON RESEARCH, LLC - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 13799045
• MDR Text Key: 287353921
• Report Number: 2523835-2022-00089
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 00380657520664
• UDI-Public: 00380657520664
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K121555
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065752066
• Device Lot Number: 13W846
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2022
• Initial Date FDA Received: 03/17/2022
• Supplement Dates Manufacturer Received: 03/22/2022; 05/26/2022
• Supplement Dates FDA Received: 04/13/2022; 06/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DIAMOX: 1 TABLET (POST-OP).; DUOVISC VISCOELASTIC SYSTEM.; OZIL TORSIONAL PHACO HANDPIECE.
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 83 KG