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

Lot Number 222

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Corneal Ulcer (1796); Neovascularization (1978); Blurred Vision (2137); Visual Impairment (2138); Eye Infections (4466); Eye Pain (4467)

Event Date 10/12/2021

Event Type  Injury  

Manufacturer Narrative

Additional information has been requested from the consumer, but not received.Device has been discarded and a device history record review 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 wore their contact lens continuously for 6-7 days.After a week, the consumer removed and disinfected the contact lens.Their left eye because red, itchy, painful, and they reported they were not able to see out of it.They went to the doctor two days later and was diagnosed with an infected corneal ulcer.The consumer was treated with tobramycin-13.6mg and vancromycin-24mg every hour for 28 hours and to return to the office in two days.The doctor indicated they should not be wearing lenses continuously.The consumer reports some of their vision has returned, but not fully and they are still being treated with steroids.Additional information has been requested but not received.

Manufacturer Narrative

The review of the manufacturing records concludes that the product was manufactured, packaged, and released according to global and plant product specifications.Bausch + lomb ultra contact lenses are approved for daily wear or extended wear up to 6 nights and 7 days with a monthly replacement schedule.The consumer also slept in lenses/showered in lenses/swum in lenses.In the instruction for users, there is a warning not to expose contact lenses to non-sterile water (e.G., tap water) while wearing them.Water can harbor microorganisms that can lead to infection.It is advised to replace lenses if they have been submersed in water when swimming in pools etc.Based on all available information, the doctor attributes the event to poor contact lens hygiene.

Event Description

Follow up with the consumer indicates that the consumer believes the vision in their eye will not return, however they do not require surgery.Medical records from the treating hospital were received.The patient reported to their ecp that they experienced left eye redness, eye pain and foreign body sensations, after wearing false eyelashes the day before.The following day the pain and vision became worse.Three days after developing the symptoms the patient visited the hospital presenting with foreign body sensation, blurry vision and concern the contact lens was still in their eye.The patient confirmed they were wearing the lenses continuously, sleeping, showering and swimming in them for two weeks at a time.Examination revealed visual acuity for the left eye distance corrected is counting fingers at 1 foot, no improvement distant pinhole with correction.Pressure is 19.Pupil test were both positive for perrl.Patient had full extra ocular movement.Slit lamp revealed the consumer had 3+ injection of the conjuntiva/sclera, cornea showed a large corneal ulcer temporally with stromal haze with small pinpoint satellite lesions nasally.Anterior chamber showed no cell, no hypopyon.The lens and iris were both normal.Vitreous showed vitreous syneresis, no cells and poor view.Fundus indicates there was poor view.The patient was treated with was fortified vancomycin/tobramycin every hour around the clock, acetaminophen prn for pain, corneal scrapings were sent for culture, gram stain calcofluor stain, page saline, no contact lenses until approved, follow up with on call cornea specialist in 2 days, consider repeat b-scan if view not improved to assess interval change in vitreous cell.The patient returned two days later and was seen by a cornea specialist and was found to have improving epithelial defect and consolidating infiltrate in the left eye.The bcva was stable, improving epithelial defect and consolidating infiltrate.The medical records confirm that the consumer had poor contact lens hygiene.The patient was treated with 5% povidone iodine solution instilled for 5 minutes and then irrigated in clinic, decrease fortified antibiotics every 2 hours for 2 days then every 3 hours until the next follow up.They were instructed to hold on initiation of steroid until gnr speciation, no contact lenses, no rubbing eye, no water directly in the eye.The patient visited the treating facility 5 days later.They had stromal whitening and corneal edema with dendritiform epithelial defect.The patient was recommended to take an antibiotic treatment based on the culture results and to take a topical steroid now given persistent epithelial defect but to start as soon as the epithelium healed.They were told to stop fortified vancomycin drops, continue fortified tobramycin 1 drop every 2 hours while awake and polysporin ointment nightly, valtrex 500mg orally two times daily, continue no contact lens wear.Appropriate contact lens wear hygiene was reviewed, recommended no swimming/showering or sleeping in lenses, limit wearing to less than 8 hours daily.

Manufacturer Narrative

Additional information b5.

Event Description

The consumer provided additional information.They indicated that they now have a corneal scar, are visually impaired, and currently have punctate plugs.The treating doctor confirmed three weeks after the initial visit the patient had confirmed a decrease in pain and increase in visual acuity.The ulcer was healing and they were instructed to discontinue prednisolone 1% and decrease fortified tobramycin 1 drop to 4 times a day.They were instructed to continue polysporin ointment nightly in the left eye, no contact lens use, and to follow up in 1-2 weeks.The patient returned to the office 2 weeks later and had improved stromal whitening with a bacillus corneal ulcer vs possible hsv stromal keratitis with ulceration.It is also noted there was signification peripheral corneal neovascularization due to contact lens over wear.Patient was instructed to increase prednisolone acetate 1% 1 drop 3 times daily, discontinue fortified tobramycin, continue polysporin ointment 1 application nightly in the left eye, and to discontinue contact lens wear.The patient returned to the office up 3 weeks later and had improved vision of 20/80 with significant stromal whitening.The patient was instructed to continue prednisolone acetate 1%, 1 drop 3 times daily in the left eye, continue polysporin ointment 1 application nightly left eye, and no contact lens use in the left eye and to follow up in 6 weeks.Patient returned to the office 6 weeks later with worsened visual acuity, likely due to ocular surface dryness.The patient was instructed to wear scleral contact lenses and proper contact lens hygiene was emphasized.The patient was fit with an lll punctal plug.They were instructed to decrease prednisolone acetate 1% 1 drop 2 times daily left eye, continue polysporin ointment 1 application nightly, use preservative free refresh/genteal, systane artificial tears every 1-2 hours as needed, and to be fit in scleral lenses.Neovascularization was improved with discontinued contact lens wear.The patient was also told to limit time in contact lenses, no need for eyeglasses as they were now given vasc20/20-1 now.They were told to use a warm facial mask for 10 minutes both sides daily and to follow up in 2 months.Patient returned to the office 2 months later with worsened vision likely due to ocular surface dryness.The patient was told again they should be fit into scleral lenses and to continue prednisolone acetate 1% 1 drop 2 times daily in the left eye, continue polysporin ointment 1 application nightly left eye and use preservative free refresh/genteal/systane artificial tears every 1-2 hours as needed, and to follow up in 4 months.

• 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 (Section G): BAUSCH & LOMB INCORPORATED; 1400 north goodman street; rochester NY 14609
• Manufacturer Contact: jennifer gamet ; 1400 north goodman street; rochester, NY 14609
• MDR Report Key: 13238033
• MDR Text Key: 283691000
• Report Number: 0001313525-2022-00005
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131208
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2022
• 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: 03/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2021
• 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: 72 YR
• Patient Sex: Female