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.

Manufacturer Narrative

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

Event Description

Additional information received from the patient on 20aug2020, which states that consultation was performed during (b)(6) (monday) and (b)(6) (wednesday), which confirmed consumer was recovered from symptoms.On (b)(6), administration of eye drops was completed and eyesight was returned to normal.It was also reported that corneal ulcer was formed near the pupil but exact location was unknown and scars on corneal surface was still remained at the time of reporting.Further information has been requested.Awaiting response.

Manufacturer Narrative

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

Event Description

Additional informed received on 17sep2020, states that, patient was recovered from corneal ulcer on (b)(6) 2020.

Manufacturer Narrative

H.3., h.6.: the complaint product was returned for evaluation and was found to meet manufacturing specifications.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).

• 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
• 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
• PMA/PMN Number: K123994
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: CBV92012961
• Device Lot Number: A0581209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2020
• Initial Date Manufacturer Received: 08/04/2020
• Initial Date FDA Received: 09/01/2020
• Supplement Dates Manufacturer Received: 08/28/2020; 09/17/2020; 10/01/2020
• Supplement Dates FDA Received: 09/10/2020; 09/23/2020; 10/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other