CONTACT LENS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-08 for CONTACT LENS manufactured by Alcon Research Llc.

Event Text Entries

[174671295] 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).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5092108
• MDR Report Key: 9569246
• Date Received: 2020-01-08
• Date of Report: 2020-01-06
• Date of Event: 2020-01-03
• Date Added to Maude: 2020-01-09
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: CONTACT LENS
• Generic Name: LENSES, SOFT CONTACT, DAILY WEAR
• Product Code: LPL
• Date Received: 2020-01-08
• Lot Number: 10439822
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ALCON RESEARCH LLC

Device Sequence Number: 2

• Brand Name: CONTACT LENS
• Generic Name: LENSES, SOFT CONTACT, DAILY WEAR
• Product Code: LPL
• Date Received: 2020-01-08
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: ALCON RESEARCH LLC

Device Sequence Number: 3

• Brand Name: CONTACT LENS
• Generic Name: LENSES, SOFT CONTACT, DAILY WEAR
• Product Code: LPL
• Date Received: 2020-01-08
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: ALCON RESEARCH LLC

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2020-01-08