MAUDE Adverse Event Report: ALCON RESEARCH LLC CONTACT LENS ; LENSES, SOFT CONTACT, DAILY WEAR

Lot Number 10439822

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/03/2020

Event Type  malfunction  

Event Description

Inserted new contact lenses of alcon air optix aqua multifocal into left and right eye.Right eye was no problem, but the left eye lens had a foreign object or other defect with the lens.I immediately tried another left lens and had the same result.I tried again on january 5th, with a 3rd lens, and again the same result of some type of defect with the lens.I attempted to contact alcon's product complaint line but was only able to leave a voicemail.Fda safety report id# (b)(4).

• Brand Name: CONTACT LENS
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): ALCON RESEARCH LLC
• MDR Report Key: 9569246
• MDR Text Key: 174671295
• Report Number: MW5092108
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• 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: 01/06/2020
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/30/2023
• Device Lot Number: 10439822
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/08/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 47 YR
• Patient Weight: 93