MAUDE Adverse Event Report: ALCON RESEARCH, LLC DAILIES AQUACOMFORT PLUS MULTIFOCAL; LENS, CONTACT, (DISPOSABLE)

Catalog Number CBV92037195

Device Problems Break (1069); Material Split, Cut or Torn (4008)

Patient Problems Corneal Scar (1793); Corneal Ulcer (1796); Unspecified Infection (1930); Irritation (1941); Pain (1994); Visual Disturbances (2140); Foreign Body In Patient (2687)

Event Date 12/13/2018

Event Type  Injury  

Manufacturer Narrative

The complaint sample has not returned for evaluation.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).

Event Description

As initially reported by a female consumer on (b)(6) 2019 through email, which had indicated that on (b)(6) 2018 she experienced pain as soon as she inserted the contact lenses to her eye and noticed upon removal that the lenses had torn while wearing.It took her one hour to remove the other half of the lens from her eye.On (b)(6) 2018, she experienced visual disturbances at close range.On "the" (b)(6) 2018, she went out to the woods and felt a visual issue and accidentally got "whip" by pine twigs against her face.She decided to remove the lenses due to discomfort and discovered that it had split.That same evening she experienced pain in her eye.The consumer visited her optician on (b)(6) 2018 and was diagnosed with a ¿big corneal ulcer on top of her pupil¿s eye¿.She was referred to a hospital and was given penicillin ointment five grams per day.On (b)(6) 2018, she revisited her ophthalmologist and was told that the first lens she used had caused the injury.She was prescribed with penicillin ointment to be taken for seven days and an unidentified ointment to be taken until night for eight weeks.On (b)(6) 2019, she visited her optician for eyeglass fitting since she was advised to discontinue contact lens wear.The consumer added that the damage on her eye was getting better but not healed.She was advised to visit her ophthalmologist after a month.The consumer also added that she had lost hours of work for a week and had a lot of expenses for travel, on call visits and patient fees.She included that part of her treatment regimen were chloramphenicol, unspecified eye drops, sodium hyaluronate and a sterile "presertive"-free eye ointment without specifying the dose and frequency.Laboratory tests were not disclosed as well.As of (b)(6) 2019, additional information was received from the consumer which indicated that she left the suspected lenses to the optician's office to be sent for investigation.She stated that in the optician's medical journal it was noted that she was diagnosed with "big corneal ulcer on top of pupil's eye".The consumer also clarified that the first lens broke on (b)(6) 2018 and she was advised to discontinue contact lens wear that day and the day after to rest the affected eye.On (b)(6) 2018, she continued to wear the lenses and it felt fine.However, the contact lens broke in her eye again the next day.The consumer specified that she had been using the daily lenses for a couple of months without any problem.As of (b)(6) 2019, new data has been received from the optician which had indicated that the ulcer covers half of the pupil affecting the top half of the visual axis.It was also stated that the lenses broke several times in the consumer¿s eye that had caused an unspecified infection.The consumer was then diagnosed with corneal ulcer on (b)(6) 2018.There were no unplanned medical or surgical intervention required to treat the incident.It was also added that the consumer had worn the soft contact lens eight to twelve hours a day and changes them daily.The consumer did not use any enzymatic cleaner, lubricant or rewetting drops, disinfecting solution, multipurpose solution or any other products together with the suspected contact lens.Medical treatment and laboratory tests were done but was not specifically mentioned.The consumer was not hospitalized but was advised to discontinue contact lens wear.It was said that the event was resolved with sequela.Additional information was received from the optician on the same day (b)(6) 2019, which stated the possibility of having an unspecified bacterial infection on the consumer¿s eye since she was given antibiotics by her ophthalmologist.The optician also noted that the ulcer left a corneal scar on the affected eye.Additional information has been requested but not yet received.

Manufacturer Narrative

Device evaluated by mfr: the complaint product was returned for evaluation and was found to meet manufacturing specifications.The device history record and sterilization record for this lot have been reviewed and found to be in compliance.The manufacturing review did not indicate that this complaint was due to the manufacturing process.No complaint or manufacturing trend was identified.The root cause could not be determined.Event: additional information.The manufacturer internal reference number is: (b)(4).

Event Description

As of 04feb2019, additional information was received from the consumer which had indicated that after she had visited her optician on (b)(6) 2018, she was diagnosed with "great corneal ulcer top pupil of the eye" due to contact lens wear and an unspecified bacteria.The consumer added that her optician communicated with the hospital where she was given penicillin ointment.It was also indicated that on (b)(6) 2018, the ophthalmologist noted that the consumer had a corneal erosion in her left eye measuring 1.2 mm.The ophthalmologist added that the wound started to heal.The consumer was treated with chloramphenicol ointment for one week, and vitamin a pos to be taken at night time to prevent recurrent corneal erosions.The consumer had continued taking vitamin a and had not resume contact lens wear.On (b)(6) 2018, the consumer stated that she visited her optician to try out new eye glasses.Her optician noted that the wound on her eye was still there and that her left eye vision was slightly changed.The consumer was advised to revisit the ophthalmologist for monitoring.On (b)(6) 2018, the consumer noted that she visited the ophthalmologist as advised.According to her ophthalmologist, the damage on her left eye had healed well but she was still recommended not to resume contact lens wear just yet.Further information cannot be obtained.

Manufacturer Narrative

Regulatory contact facility and manufacturing contact facility name.The manufacturer internal reference number is: (b)(4).

• Brand Name: DAILIES AQUACOMFORT PLUS MULTIFOCAL
• Type of Device: LENS, CONTACT, (DISPOSABLE)
• Manufacturer (Section D): ALCON RESEARCH, LLC; 11440 johns creek parkway; duluth GA 30097
• MDR Report Key: 8292746
• MDR Text Key: 134600191
• Report Number: 1065835-2019-00002
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• PMA/PMN Number: K123994
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: CBV92037195
• Device Lot Number: A0514503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2019
• Date Manufacturer Received: 03/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other