MAUDE Adverse Event Report: BAUSCH & LOMB INCORPORATED BIOTRUE ONEDAY(NESOFILCON A)CONTACT LENS; LENS, CONTACT, DISPOSABLE

Lot Number 222

Device Problems Expulsion (2933); Insufficient Information (3190)

Patient Problem Corneal Abrasion (1789)

Event Date 03/05/2021

Event Type  Injury  

Manufacturer Narrative

The product has been discarded and is not available for return.An evaluation of the manufacturing records is in progress.Based on all available information, no causal factors can be determined and no conclusion can be drawn.

Event Description

A consumer reported that they experienced a cut in their right eye after removing a contact lens.Medical information was received from the treating doctor and confirmed that the patient was seen over the course of 3 months for recurrent corneal erosion.The patient was first seen in (b)(6) 2021 for light sensitivity and severe pain after removal of the contact lens.During the initial exam the patient presented with injection and an irregular right cornea.The patient was initially diagnosed with a right eye corneal abrasion.The patient was prescribed an antibiotic for treatment.The patient was seen approximately one week later.The exam concluded that the abrasion had healed and no further treatment was necessary.Approximately one month later the patient was seen again for a sharp pain in the right eye.Upon examination the doctor observed scant mucoid discharge in the tear fil of the right conjunctiva and irregular corneal staining with epithelial defect was also present in the right eye.The right anterior chamber was deep with 1+cell.The patient was diagnosed with a corneal abrasion that had reopened after removing their contact lens.The doctor also advised that the patient had recurrent erosion.During this appointment the doctor discussed the possibility of the patient needing superficial keratectomy to treat the erosion.The patient was prescribed two different antibiotics for treatment.The patient was seen three days later for a follow up appointment.The patient presented with irritation and mild blurry vision but overall felt their symptoms were improving.During the exam injection of the right conjunctiva was observed and irregular epithelial with minimal staining of the right cornea was present.An occasional cell was also noted in the right anterior chamber.The patient was diagnosed with recurrent erosion of the right cornea and an almost healed abrasion.The patient was advised to continue with the two antibiotics that were prescribed at the previous appointment and fitted with a bandage contact lens that needs to be worn for at least three weeks.During this appointment the patient decided that they would like to try other options before undergoing a superficial keratectomy.The patient was seen for a follow up appointment exactly three weeks later.The examination concluded that the patient had fully healed and the bandage contact lens was removed.

Manufacturer Narrative

A review of the manufacturing records concludes that the product was manufactured, packaged, and released according to global and plant product specifications.Based on all available information, no causal factors can be determined and no conclusion can be drawn.

• Brand Name: BIOTRUE ONEDAY(NESOFILCON A)CONTACT LENS
• Type of Device: LENS, CONTACT, DISPOSABLE
• Manufacturer (Section D): BAUSCH & LOMB INCORPORATED; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB; unit 424/425, cork road; industrial estate; waterford ; EI
• Manufacturer Contact: jennifer gamet ; 1400 n goodman street; rochester, NY 14609
• MDR Report Key: 12714616
• MDR Text Key: 279044712
• Report Number: 0001313525-2021-00131
• Device Sequence Number: 1
• Product Code: MVN
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K113703
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2021
• 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: 10/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female