MAUDE Adverse Event Report: JOHNSON AND JOHNSON VISION CARE INC. - US ACUVUE® VITA¿; LENSES, SOFT CONTACT, EXTENDED WEAR

Catalog Number ATL

Device Problem No Apparent Adverse Event (3189)

Patient Problems Corneal Abrasion (1789); Pain (1994); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On 05feb2018 an email was received from a patient¿s (pt) family member who reported the pt removed an ¿acuvue silicone¿ contact after a normal day and reported severe pain (affected eye was not provided).The pt went to an eye care provider (ecp) the following day after reporting ¿unbearable pain that evening¿.The pts family member reported ¿it was because of the acuvue silicone contacts and how badly they are made¿.The pts family member reported the pt was diagnosed with an ¿epithelial abrasion¿.Pt is in ¿day three of recovery and is still in pain but gaining the eye sight back¿.The suspect product was reported as acuvue vita brand contact lens.No additional information was provided.On 14feb2018 a call was placed to the pts family member who could not talk at the time.Requested the family member to call to provide additional medical and product information.No information was provided.On 01mar2018 a call was placed to the ecp number provided in the initial email.Additional medical information requested, but no additional medical information has been received.No additional medical information has been received after multiple attempts.The date of the event is unknown.The lot number is unknown and it is unknown if the suspect lens was available for evaluation.The affected eye is also unknown.This event is being reported as a worst-case event as the diagnosis and treatment were unable to be verified.If additional information is received it will be reported within 30 days of receipt.Serious reportable event trends are reviewed quarterly in franchise management review meetings.

Manufacturer Narrative

On (b)(6) 2018 the patient (pt) called and provided additional medical information: pt can¿t recall the exact date of event, but confirmed it was in (b)(6) 2018.Pt reported ¿the eyes were kinda bothering the pt¿ so the pt removed the lenses that night.The pt reported that the eye care provider (ecp) told the pt that while removing the od suspect lens, the pt ¿removed about 70% of the cornea¿ and diagnosed the pt with corneal epithelial erosion.Pt reported the ecp advised that ¿it went down to the root.¿ pt was prescribed ketorolac for pain every 3 hours and an antibiotic eye drop (name of the eye drop was not known) every 4 hours for at least 5 days.The pt was unsure how long the eye drops were prescribed.The pt could not recall how many days the suspect lens had been worn at the time of the event, but reported the ¿lenses tend to get stiff around 2 weeks and the pt will have to replace them¿.The pt reported using biotrue contact lens solution and does not sleep in the lenses.The pt reported the lenses have not been lasting the month.The pt had an eye exam yesterday and refit into acuvue oasys brand contact lenses.Pt reported vision was bad in the od after the event and pt thought he/she was going ¿blind¿, but the vision improved after about 5 days and pt reports it is fine now.On (b)(6) 18 a call was placed to the pts ecp and a representative provided additional medical information: the representative reported the pts first visit was on (b)(6) 2018.Pt was diagnosed with corneal erosion od; pt was prescribed ketorolac qid, blink tears, and ocuflox qid.Pt had a follow up visit the following day and advised to continue medications for 4 more days and follow up.Pt had an additional follow-up visit on 05feb2018 and advised to continue treatment and to lubricate eyes well with the blink tears, use 6 times a day.The pt was seen for a follow-up visit yesterday and advised to discontinue the ketorolac and ocuflox, but to continue the blink tears; no indication in the pts chart that states pt has permanent damage or scarring; pts has a new prescription for acuvue oasys brand contact lenses.No additional medical information was provided.The suspect lens was discarded.A lot history review was performed and revealed the following: the batch record did not show any abnormalities in monomer and solution testing.All parameters tested were within specification.All sterilization requirements were successfully completed.Lot b00mztx was produced under normal conditions.If additional information is received it will be reported within 30 days of receipt.Serious reportable event trends are reviewed quarterly in franchise management review meetings.(b)(4).

Manufacturer Narrative

On (b)(6) 2018 during a file review it was noted that there was a date error on the initial mdr in section., "(b)(6) 2018" should be (b)(6) 2018.

• Brand Name: ACUVUE® VITA¿
• Type of Device: LENSES, SOFT CONTACT, EXTENDED WEAR
• Manufacturer (Section D): JOHNSON AND JOHNSON VISION CARE INC. - US; 7500 centurion parkway; jacksonville FL
• MDR Report Key: 7313748
• MDR Text Key: 101511175
• Report Number: 1057985-2018-00023
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• PMA/PMN Number: K16021 2
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/01/2022
• Device Catalogue Number: ATL
• Device Lot Number: B00MZTX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/05/2018
• Patient Sequence Number: 1
• Treatment: BIOTRUE CONTACT LENS SOLUTION
• Patient Outcome(s): Other; Required Intervention