MAUDE Adverse Event Report: ALCON RESEARCH, LLC. PRECISION 1 DAILY CONTACT LENS; LENSES, SOFT CONTACT, DAILY WEAR

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Dry Eye(s) (1814); Headache (1880); Keratitis (1944)

Event Date 09/18/2021

Event Type  Injury  

Event Description

I had a patient with keratitis and dry eye syndrome who also suffered from headaches after months of wearing contact lenses prescribed by (b)(6) using their fraudulent quackery "vision exam" that is designed to rubber-stamp self-prescribed lenses to make sales to the detriment of patient health and with callous disregard for standard of care.Fda safety report id# (b)(4).

• Brand Name: PRECISION 1 DAILY CONTACT LENS
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): ALCON RESEARCH, LLC.
• MDR Report Key: 12513096
• MDR Text Key: 272951868
• Report Number: MW5104132
• 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: Physician
• Type of Report: Initial
• Report Date: 09/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1