MAUDE Adverse Event Report: ALCON CONTACT LENS; INTRAOCULAR LENS

Model Number 00846566555260

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Rash (2033)

Event Date 04/10/2018

Event Type  Injury  

Event Description

My son obtained alcon air optix contact lens.Upon using it, he started experiencing severe rashes and other complications in his eyes.We contacted alcon and we were told that they will reimburse us for getting a new rx and doctor visit.We had spent over (b)(6) dollars and is waiting for over 4 months and alcon keeps saying that they are upgrading their accounts payable and has no timeline for reimbursing us.

• Brand Name: CONTACT LENS
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON
• MDR Report Key: 7424887
• MDR Text Key: 105420623
• Report Number: MW5076440
• Device Sequence Number: 1
• Product Code: HQL
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 04/10/2018

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 Expiration Date: 12/31/2021
• Device Model Number: 00846566555260
• Device Catalogue Number: 846566555260
• Device Lot Number: 10339563
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/11/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 14 YR