MAUDE Adverse Event Report: BAUSCH & LOMB INCORPORATED ULTRA (SAMFILCON A) CONTACT LENS; LENSES, SOFT CONTACT, DAILY WEAR

Lot Number 222

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Corneal Ulcer (1796); Unspecified Infection (1930); Discomfort (2330)

Event Date 12/11/2020

Event Type  Injury  

Manufacturer Narrative

The retail location confirmed that product has been discarded.Sealed lenses were returned from the same complaint lot, they were evaluated and it was determined the lenses were in specification.A review of the device history records is in progress.Based on all available information, no causal factors can be determined and no conclusion can be drawn.

Event Description

A retail location reported that a patient inserted their contact lens and experienced discomfort and visited an eye clinic.Follow up with the retail location indicated that the patient visited the doctor and was diagnosed with a right eye infective corneal ulcer.The patient was prescribed gatiflo ophthalmic solution 6 times a day and to temporarily discontinue contact lens wear.The patient followed up with the doctor a week later and they had resumed lens wear and fully recovered.It was confirmed that cultures were not taken of the eye.Additional information was requested, but direct contact with the doctor was denied.

Manufacturer Narrative

A review of the manufacturing records concludes that the product was manufactured, packaged and released according to global and plant product specifications.The complaint lenses were not returned, so evaluations could not be completed.Two sealed lenses were returned and found to be within all required specifications.Based on all information, no causal factors can be determined and no conclusion can be drawn.

• Brand Name: ULTRA (SAMFILCON A) CONTACT LENS
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): BAUSCH & LOMB INCORPORATED; 1400 north goodman street; rochester NY 14609
• MDR Report Key: 11344032
• MDR Text Key: 232408775
• Report Number: 0001313525-2021-00021
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): Y
• PMA/PMN Number: K131208
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 01/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2021
• 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: 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention