MAUDE Adverse Event Report: ALCON RESEARCH, LLC DAILIES TOTAL 1; LENSES, SOFT CONTACT, DAILY WEAR

Catalog Number CBVUNK00017

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Corneal Ulcer (1796); Fungal Infection (2419)

Event Type  Injury  

Manufacturer Narrative

No sample received at time of complaint investigation.The investigation consisted of a review of the complaint trend for categories h-corneal ulcer infectious and product use/user technique for delefilcon product.A product specific investigation was not performed as no lot number was available.No sample evaluation was completed as no product was returned.There were no adverse trends identified for complaint h-corneal ulcer infectious and product use/user technique for delefilcon product from (b)(6) 2017 ¿ (b)(6) 2019.A root cause was not confirmed.No capa is required and no further action will be taken by the manufacturing site as no specific root cause was identified.Trends and complaint investigations will continue to be monitored and action taken if warranted.The manufacturer internal reference number is: (b)(4).

Event Description

It was reported by an ecp via email on (b)(6) 2019 that he had seen a discussion on social media that includes adverse events for the alcon contact lens.In that social media comment posted on (b)(6) 2019, another ecp stated that he had seen four corneal ulcers in the past six months, including in his son who had a fungal infection.The other unidentified patients had a confirmed pseudomonas and a probable acanthamoeba.All patients were not compliant with daily wear disposal.The comment poster's son also slept in the lens on occasion.Symptom resolution is unknown.No further information is available.

• Brand Name: DAILIES TOTAL 1
• 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: cindy milam ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152231
• MDR Report Key: 8866431
• MDR Text Key: 153550173
• Report Number: 1065835-2019-00014
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113168
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: CBVUNK00017
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 16 YR