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

Lot Number 222

Device Problem Insufficient Information (3190)

Patient Problems Corneal Edema (1791); Corneal Ulcer (1796); Dry Eye(s) (1814); Glaucoma (1875); Hypopyon (1913); Keratitis (1944); Fungal Infection (2419)

Event Date 05/23/2019

Event Type  Injury  

Manufacturer Narrative

The product is not available for return.Based on all available information, no causal factors can be determined and no conclusion can be drawn.

Event Description

A consumer reported that they had experienced a corneal ulcer after wearing a contact lens.The consumer reported seeing three different doctors for the issue.The consumer first visited an optometrist last year.The optometrist reported that bulbar injection, corneal edema, corneal staining, microbial keratitis and neovascularization was observed in the right eye.The patient also has a residual central corneal scar in the same eye.The patient was diagnosed with a central corneal ulcer and was treated with tobramycin and maxitrol.The optometrist indicated the event is not life threatening, however it did result in permanent loss of vision.The patient was referred to an ophthalmologist.The patient¿s medical records indicate the ophthalmologist performed cultures on an unknown date that showed no growth at that time.Fungal infection was suspected.Patient was treated with natamycin drops, voriconazole oral and drops, phmb, fortified vanco and tobramycin drops.There was no further improvement and the patient was referred to another ophthalmologist.Three weeks after the optometrist visit, the patient was seen by the second ophthalmologist.It is noted in the patient¿s record that at initial visit, the patient reported they were sanding wood while wearing safety glasses and contact lenses.The patient informed them that it felt like something entered the right eye.Corneal scraping was performed and was positive for fungal aspergillus.Three months later, the patient had a corneal transplant.Since then and until present, the patient has been seen for a corneal ulcer, fungal ulcer aspergillus, hypopyon, ocular hypertension, blepharitis, squamous, dry eye disease and keratoconjunctivitis sicca.One month ago, the patient was seen to monitor best corrected visual acuity in the right eye since the corneal transplant and for a macula scan to rule out maculopathy.The ophthalmologist reported that the patient has been compliant with their dry eye regimen and the vision in their right eye was better at the most recent visit.The patient was diagnosed with myopia and dry eye disease in both eyes and cystoid macular edema, corneal transplant, glaucoma and pseudomyopia in their right eye.The patient was prescribed combigan regener-eyes, cequa and flarex.The patient was also treated with oasis tears, retaine pm, cold compress and a lid scrub.The patient has a history of corneal ulcer, cataract surgery and glaucoma.The patient also had exposure to keratopathy in the right eye and dry eye disease in both eyes.

Manufacturer Narrative

Based on all information, no causal factors can be determined and no conclusion can be drawn.

Event Description

Additional information was received from one of the three physicians that evaluated the patient.This physician indicates the patient is not compliant with contact lens care and are considered a ''contact lens abuser''.There was no known relevant ocular or medical history at the time of the exam.The patients symptoms at the time of the visit were blurry vision, pain, and light sensitivity.The patient had right eye hypopyon 5%, dense white corneal infiltrate's inferior nasal and a central infectious corneal ulcer.Microbial keratitis, neovascularization, and a corneal scar were not observed by this physician.Cultures were taken, there was no fungal growth but there were ''many white blood cells'' detected.The diagnosis was mycotic corneal ulcer.The consumer was prescribed fortified tobramycin, fortified vancomycin, natacyn, voriconazole, and the patient was instructed to temporarily discontinue contact lens wear.The patient was referred to a corneal specialist.And this office is unsure if the patient has recovered.The form completed by this physician indicates the event was not life threatening.

Event Description

Additional medical information was received from the consumer.The form indicates that one of the treating physicians scheduled a surgery and two post-op appointments for the consumer.The office confirmed that a conjunctivoplasty was performed on the patient and two post-op appointments were scheduled.The first was scheduled for the day after surgery and the second appointment was made six days post-surgery.

Manufacturer Narrative

Multiple attempts have been made to obtain information regarding the patients outcome with surgery and follow up visits, but have been unsuccessful.Based on all information, no causal factors can be determined and no conclusion can be drawn.

Event Description

Additional information has been received, the consumer previously reported information regarding this event to bausch and lomb and contacted the fda with additional information.Included in the report received by the fda, the consumer indicated a cornea correction surgery and cataract surgery were necessary for their recovery.

Manufacturer Narrative

The consumer¿s eye care professional¿s office confirmed a corneal transplant surgery was scheduled for (b)(6) 2021.A corneal transplant will be the only eye surgery necessary at this time.The patient has recovered from their conjunctivoplasty.

Manufacturer Narrative

The consumer's eye care professional has confirmed that the patient is healing from the corneal transplant surgery.Following their surgery the consumer is using prednisolone eye drops.There is no further information at this time.

• 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
• Manufacturer (Section G): BAUSCH & LOMB INCORPORATED; 1400 north goodman street; rochester NY 14609
• Manufacturer Contact: jennifer gamet ; 1400 north goodman street; rochester, NY 14609 ; 5853386853
• MDR Report Key: 10585591
• MDR Text Key: 208511288
• Report Number: 0001313525-2020-00142
• 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: Consumer,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/01/2005,06/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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 Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 08/26/2020
• Initial Date FDA Received: 09/25/2020
• Supplement Dates Manufacturer Received: 03/09/2021; 08/26/2020; 06/21/2021; 10/15/2021
• Supplement Dates FDA Received: 04/07/2021; 05/11/2021; 07/14/2021; 11/12/2021
• 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
• Patient Age: 44 YR
• Patient Sex: Male