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

Lot Number R62011692

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

Patient Problems Bacterial Infection (1735); Corneal Scar (1793); Corneal Ulcer (1796); Irritation (1941); Swelling (2091); Blurred Vision (2137)

Event Date 10/22/2018

Event Type  Injury  

Manufacturer Narrative

The consumer has discarded the lens.They provided two possible lot numbers for the complaint lens.A review of the lot 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

Consumer reported that they inserted a new lens on (b)(6) 2018 and wore it continuously until (b)(6) while spending those days on a boat in the ocean.They began to develop irritation in the left eye.Upon visiting a doctor cultures were performed and the results revealed an infection that one can obtain from a ''cow udder''.The consumer reports they initially visited the retail location that fit them into the lenses.The retail location did not examine, diagnose, or treat the consumer.Instead they referred the consumer to an ophthalmologist.The patient was seen by the ophthalmologist on (b)(6) 2018.Information obtained from the ophthalmologist¿s office indicated that the patient had taken a 2-3 week contact lens holiday.When the patient resumed lens wear they experienced irritation, blurry vision and swelling in the left eye.The patient was diagnosed with left eye corneal ulcer and was referred to a corneal specialist the following day.No treatment was provided by ophthalmologist.Information obtained from the corneal specialist¿s office indicated that the patient was seen on (b)(6) with left eye irritation, blurred vision and a corneal ulcer ¿ which they had been experiencing for two days.A culture was taken on this day and the results indicated (b)(6).The patient was prescribed vancomycin and ofloxacin eye drops to be used every hour while awake and every three hours while asleep.As the patient recovered, they were instructed to taper use of the eye drops.As of november 13, 2018 the patient had recovered with no loss of vision.However, a central stromal scar remains.According to the corneal specialist, the patient is not compliant with contact lens wear and does not obey prescribed wear times.The corneal specialist attributes the event to the patient¿s non-compliance with proper contact lens wear, not the contact lens itself.

Manufacturer Narrative

A review of the lot device history records concludes that the product was manufactured, packaged and released according to global and plant product specifications.  the corneal specialist seen by the patient reported that the patient is not compliant with contact lens wear and does not obey prescribed wear times.The corneal specialist attributes the event to the patient¿s non-compliance with proper contact lens wear, not the contact lens itself.

Manufacturer Narrative

Sealed product was returned from the consumer.The returned product was evaluated and was found to be within specification.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: 8232169
• MDR Text Key: 132556319
• Report Number: 0001313525-2019-00009
• 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: consumer,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/30/2019
• Device Lot Number: R62011692
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other