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

Catalog Number CBV92001362

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Erosion (1750)

Event Date 11/20/2021

Event Type  Injury  

Event Description

A consumer reported experiencing ¿light corneal erosion¿ in an eye a day after removing a torn lens from the eye.The consumer informed that part of the torn lens stayed in the eye and it was difficult to remove.Additional information has been requested for this event, however, not yet received.

Manufacturer Narrative

The complaint sample has not returned for evaluation; the lot number is unknown.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.(b)(4).

Event Description

Additional information received which showed left eye was involved.It took half a day to remove the remaining part of the lens out of the eye.Consumer used eye drop and able to remove lens.It was also reported that on next day consumer accidentally poked eye and got a corneal erosion.Consumer sought the emergency department and got antibiotic eye drops and wetting drops.Consumer suspended wearing contact lenses for the next weeks.The current status of consumer's eye is resolved.No medical document expected.

Manufacturer Narrative

H3, h6: the actual complaint product was not returned for evaluation.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).

• 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: 12924209
• MDR Text Key: 281672823
• Report Number: 1065835-2021-00007
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K072777
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/02/2022

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: Lay User/Patient
• Device Catalogue Number: CBV92001362
• Device Lot Number: A0627895
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/22/2021
• Initial Date FDA Received: 12/03/2021
• Supplement Dates Manufacturer Received: 02/18/2022
• Supplement Dates FDA Received: 03/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female