MAUDE Adverse Event Report: ALCON RESEARCH, LLC. OPTIFREE PURE MOIST CONTACT SOLUTION; ACCESSORIES, SOFT LENS PRODUCTS

Lot Number 118Y4

Device Problems Device Emits Odor (1425); Product Quality Problem (1506)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Contact solution has a moldy smell.Multiple bottles from same lot.Reference reports mw5115412, mw5115413 and mw5115414.

• Brand Name: OPTIFREE PURE MOIST CONTACT SOLUTION
• Type of Device: ACCESSORIES, SOFT LENS PRODUCTS
• Manufacturer (Section D): ALCON RESEARCH, LLC.
• MDR Report Key: 16486006
• MDR Text Key: 310788082
• Report Number: MW5115411
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 118Y4
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Sex: Female