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

Lot Number R82020868

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

Patient Problems Bacterial Infection (1735); Corneal Scar (1793); Corneal Ulcer (1796); Hypopyon (1913); Pain (1994); Red Eye(s) (2038); Staphylococcus Aureus (2058); Loss of Vision (2139)

Event Date 11/21/2018

Event Type  Injury  

Manufacturer Narrative

Additional medical information was requested from the doctor, but not received.The complaint lens was discarded by the consumer.A review of the lot device history records is in progress.Based on available information, no causal factors can be determined and no conclusion can be drawn.

Event Description

Practitioner reported they had a patient who was previously wearing competitor¿s lens, they were fit into the complaint lens, plano power, for one day.After sleeping in the lens they returned to the office the following day, (b)(6) 2018, with right eye hypopyon, pain, light sensitivity, bulbar injection and a ring ulcer in the central cornea.The practitioner prescribed prokera lens (amniotic membrane), besivance, tobrex, pred forte, ilevro, oral doxycycline, and artificial tears.A corneal scraping was taken, which was (b)(6) for (b)(6).They had a follow up appointment (b)(6) where the doctor continued the same treatment, it was too early to determine the duration of treatment.The patient currently has loss of vision; it is unclear if it will be permanent.The patient has no history of infections.The doctor confirmed they are unsure of the causality of the event.It was confirmed the event is not life threatening, it is too early to tell if the event will result in permanent impairment of a body function or permanent damage to a body structure.The doctor confirmed that the event did necessitate medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.Additional medical information has been requested, but not received.

Event Description

Follow up event information received by treating doctor.Patient was wearing the complaint lens as a bandage lens after an unspecified corneal procedure.A corneal specialist in the same office examined the patient and determined they were a mrsa carrier.The patient is also employed at a hospital.These factors could have led to the onset of the event.Both doctors agree that the event was not caused by the complaint lens.The patient is still currently under treatment with a central corneal scar.According to the doctor, although the patients vision has improved since the onset, there will most likely be permanent loss of vision.

Manufacturer Narrative

Follow up with the treating doctors confirmed they do not attribute the event to the lens but a preexisting condition.The review of the manufacturing records concludes that the product was manufactured, packaged and released according to global and plant product specifications.The investigation does not provide evidence that the product contributed to the event.Based on all available 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: 8174531
• MDR Text Key: 130991941
• Report Number: 0001313525-2018-00237
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 11/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/08/2021
• Device Lot Number: R82020868
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACUVUE OASYS
• Patient Outcome(s): Required Intervention