MAUDE Adverse Event Report: ALCON RESEARCH, LLC DAILIES AQUACOMFORT PLUS; LENSES, SOFT CONTACT, DAILY WEAR

Catalog Number CBVUNK00012

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Corneal Abrasion (1789); Eye Burn (2523); Eye Infections (4466)

Event Date 12/17/2023

Event Type  Injury  

Manufacturer Narrative

H.3., h.6.: the lot number was not provided and the complaint sample was not made available for evaluation.The manufacturing review did not indicate that this complaint was due to the manufacturing process.No complaint or manufacturing trend was identified.The root cause could not be determined.The manufacturer internal reference number is: (b)(4).

Event Description

A non-health care professional reported that the consumer had experienced abrasion on cornea which causes infection and burning in both eyes.This occurred due to wrong combination of the product.The consumer had immediately stopped using the products.The current status of the consumer¿s eyes was unknown at the time of this report.Additional information has been requested but not yet received at the time of this report.

Event Description

A non-health care professional reported that the consumer had experienced abrasion on cornea which causes infection and burning in both eyes.Additionally it was reported that consumer used daily wear contact lens with the lens care solution.The consumer had immediately stopped using the products.The current status of the consumer¿s eyes was unknown at the time of this report.Additional information was requested but could not obtained as the contact details of the consumer was not available.

Manufacturer Narrative

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

Manufacturer Narrative

H.3., h.6.: the actual complaint product was not returned for evaluation.A retained sample from the same complaint lot was tested and was found to meet manufacturing specifications.A trend related investigation was performed; no trend could be identified.The device history record and sterilization record for this lot have been reviewed and found to be in compliance.There was no nonconformity or deviations during the manufacturing process which related to the nature of the complaint.The root cause could not be determined.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

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

• Brand Name: DAILIES AQUACOMFORT PLUS
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): ALCON RESEARCH, LLC; 11440 johns creek parkway; duluth GA 30097
• Manufacturer (Section G): ALCON RESEARCH, LLC; 11440 johns creek parkway; duluth GA 30097
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 18423118
• MDR Text Key: 331767981
• Report Number: 1065835-2024-00001
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K072777
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/01/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: CBVUNK00012
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: AOSEPT PLUS DISINFECTING SOLUTION
• Patient Outcome(s): Required Intervention; Other