MAUDE Adverse Event Report: BAUSCH & LOMB ULTRA ONEDAY CONTACT LENS; LENS, CONTACT, (DISPOSABLE)

Lot Number 222

Device Problem Insufficient Information (3190)

Patient Problems Corneal Ulcer (1796); Fungal Infection (2419)

Event Type  Injury  

Manufacturer Narrative

Additional medical and product information has been requested, but not received.Based on all information, no causal factors can be determined and no conclusion can be drawn.

Event Description

A doctor's office reported that the patient developed a fungal ulcer after wearing contact lenses.Additional information has been requested but not received.

• Brand Name: ULTRA ONEDAY CONTACT LENS
• Type of Device: LENS, CONTACT, (DISPOSABLE)
• Manufacturer (Section D): BAUSCH & LOMB; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): BAUSCH & LOMB; 1400 north goodman street; rochester NY 14609
• Manufacturer Contact: jennifer gamet ; 1400 north goodman street; rochester, NY 14609
• MDR Report Key: 11645048
• MDR Text Key: 252314321
• Report Number: 0001313525-2021-00031
• Device Sequence Number: 1
• Product Code: MVN
• Combination Product (y/n): Y
• PMA/PMN Number: K200528
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial
• Report Date: 02/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 222
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1