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

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

Patient Problems Corneal Ulcer (1796); Pain (1994); Red Eye(s) (2038); Loss of Vision (2139); Discharge (2225)

Event Date 08/14/2019

Event Type  Injury  

Manufacturer Narrative

Lot information provided by the reporting doctor was determined to be invalid.Product was not available to be returned for analysis as it was discarded.Based on all available information, no causal factors can be determined and no conclusion can be drawn.

Event Description

A doctor reported that a patient came into their office with complaints of pain, redness and poor visual acuity in the left eye.It was also noted on this day that the patient had discharge from their eye.The doctor reported that on the following day upon examination, the patient¿s cornea was white and had very bad inflammation.Two days post the initial visit to the doctor, the patient returned to the office.The doctor stated that upon examination, the cornea was still inflamed and white.In addition, a contact lens was discovered under the patient¿s eyelid and had to be removed.The patient was unaware that the lens was under their eyelid.The doctor diagnosed the patient with a corneal ulcer that was located 1 millimeter below visual access in the pupil.Cultures were not taken of the eye, however, the doctor stated that the corneal ulcer was not infectious.As treatment, the doctor prescribed erythromycin ointment, besivance, durezol, cyclopentolate and homatropine for a duration of 2 weeks.The patient has returned to the doctor¿s office for follow up visits.Examination of the eye revealed that it is no longer white, however there is a remaining scar.The doctor stated that the patient will have permanent vision loss.Previously the patient could see 20/20 and, when fully healed, at best would see 20/40.The patient has no history of ophthalmic diseases, however does suffer from rheumatoid arthritis.The doctor indicates the patient is compliant with contact lens wear and care, except for the office visit in which the lens was found under the patient¿s eyelid.The doctor is unsure of the likely cause of the event as it could have been caused by either the contact lens or the patient¿s rheumatoid arthritis.

• Brand Name: ULTRA FOR PRESBYOPIA CONTACTLENS
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): BAUSCH & LOMB INCORPORATED; 1400 north goodman street; rochester NY 14609
• Manufacturer Contact: jennifer gamet ; 1400 north goodman street; rochester, NY 14609 ; 5853388549
• MDR Report Key: 9146888
• MDR Text Key: 165967220
• Report Number: 0001313525-2019-00152
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K131208
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,09/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2019
• 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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 09/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention