MAUDE Adverse Event Report: ALCON RESEARCH, LLC DAILIES AQUACOMFORT PLUS MULTIFOCAL LENS, CONTACT, (DISPOSABLE)

Catalog Number CBV92012961

Device Problem Material Split, Cut or Torn (4008)

Patient Problems Corneal Ulcer (1796); Irritation (1941)

Event Date 07/18/2020

Event Type  Injury  

Manufacturer Narrative

The complaint sample has been returned for evaluation. 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: (b)(4).

Event Description

As initially reported by a female consumer via website on (b)(6) 2020, consumer stated that on (b)(6) 2020, she experienced irritation while wearing the lens, when removed the lens she found it torn. The consumer also experienced red eye. On (b)(6) 2020, consumer was diagnosed with corneal ulcer. Consumer was recommended to apply anti-bacterial and antibiotic eye drops 6 times per day and eye ointment to be applied once per day before going to sleep. Iv drip was also give. Consumer visited the doctor daily. On (b)(6) 2020 symptoms were resolved.

• Brand Name: DAILIES AQUACOMFORT PLUS MULTIFOCAL
• Type of Device: LENS, CONTACT, (DISPOSABLE)
• 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 ; 8175514979
• MDR Report Key: 10476628
• MDR Text Key: 205366972
• Report Number: 1065835-2020-00011
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K123994
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: CBV92012961
• Device Lot Number: A0581209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2020

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/01/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/10/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 09/01/2020 Patient Sequence Number: 1