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

Lot Number LEFT: NO692897

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/28/2021

Event Type  Injury  

Event Description

Caller stated that his left contact lens got stuck to his eyes when he tried removing it.While he was removing the lens, it broke and was only able to remove parts of it.He flushed his eyes with water, but it was still difficult to remove, so he contacted a medical professional who assisted in the removal of the remainder of the broken lens.Caller also stated that the right contact lens was unable to be removed, he tried flushing his eye with water but could not remove it.The medical profession also removed the right lens.He further stated that he wears his contact lens everyday and on this day he only has his lens on for less than four hours.

• Brand Name: DAILIES COMFORT PLUS
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): ALCON RESEARCH, LLC
• MDR Report Key: 11760757
• MDR Text Key: 248905173
• Report Number: MW5101130
• Device Sequence Number: 1
• Product Code: LPL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/30/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: LEFT: NO692897
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 91