MAUDE Adverse Event Report: BAUSCH & LOMB INCORPORATED BIO TRUE CONTACT LENSES LENSES, SOFT CONTACT, DAILY WEAR

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem Insufficient Information (4580)

Event Date 11/12/2021

Event Type  malfunction  

Event Description

Contact lens with black flecks when i opened the package. Fda safety report id# (b)(4).

• Brand Name: BIO TRUE CONTACT LENSES
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): BAUSCH & LOMB INCORPORATED
• MDR Report Key: 12828953
• MDR Text Key: 280955980
• Report Number: MW5105377
• Device Sequence Number: 1
• Product Code: LPL
• 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: 11/12/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No Answer provided