MAUDE Adverse Event Report: BAUSCH & LOMB INCORPORATED BAUSCH AND LOMB ULTRA FOR PRESBYOPIA; LENSES, SOFT CONTACT, DAILY WEAR

Device Problem Use of Device Problem (1670)

Patient Problem Corneal Infiltrates (2231)

Event Date 12/17/2021

Event Type  Injury  

Event Description

Corneal infiltrate and corneal hypoesthesia secondary to soft contact lens overwear.Fda safety report id# (b)(4).

• Brand Name: BAUSCH AND LOMB ULTRA FOR PRESBYOPIA
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): BAUSCH & LOMB INCORPORATED
• MDR Report Key: 13059805
• MDR Text Key: 282633818
• Report Number: MW5106193
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White