MAUDE Adverse Event Report: JOHNSON AND JOHNSON VISION - US UNK-SOFT CONTACT LENSES

Catalog Number UNK-SOFT CONTACT LENSES

Device Problem No Apparent Adverse Event (3189)

Patient Problems Corneal Ulcer (1796); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).

Event Description

On (b)(6) 2017 a call was received from a patient (pt) in (b)(6) who reported while wearing an unknown acuvue brand contact lens, he/she was diagnosed with a corneal ulcer in the left eye in 2016.The pt could not recall the exact date of the event.The pt reported left eye discomfort for a couple of days, then went to an eye care provider (ecp) who diagnosed the corneal ulcer in the left eye.The pt was prescribed sophixin (ciprofloxacin and dexamethasone) ophthalmic solution, three drops in the left eye five times daily.The pt reported the treatment lasted for one month.Pt reported he/she did not sleep in the lenses and had a monthly replacement schedule.The pt could not recall what disinfectant solution was used at the time of the event.The suspect lot number is unknown and the suspect lens was discarded.On (b)(6) 2017 a call was placed to the pts treating ecps office and a representative reported that no information is provided by telephone.An interview would need to be scheduled with the doctor for additional medical information.On (b)(6) 2017 a medical interview was scheduled with the clinic treating ecp for additional information.On (b)(6) 2017 an email was received our affiliate in (b)(6) who reported the clinic refused to provide any medical information at the medical interview.It was advised the medical information can only be released to the pt directly.No additional medical information was provided.On (b)(6) 2017 a call was placed to the pt to see if he/she could get the medical records from the clinic for the 2016 corneal ulcer event.The pt refused to go to the clinic to request the medical report.No additional medical information was received.No additional medical information is expected.The 2016 corneal ulcer event will be reported as a worst-case event as the diagnosis and treatment were unable to be verified with the pts treating ecp.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.

• Brand Name: UNK-SOFT CONTACT LENSES
• Type of Device: SOFT CONTACT LENSES
• Manufacturer (Section D): JOHNSON AND JOHNSON VISION - US; 7500 centurion parkway; jacksonville FL
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433364
• MDR Report Key: 7072944
• MDR Text Key: 93429626
• Report Number: 1057985-2017-00137
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: MX
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/08/2017

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 Catalogue Number: UNK-SOFT CONTACT LENSES
• Device Lot Number: UNK-UNK-SOFT CONTACT LENSES
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/08/2017
• Initial Date FDA Received: 11/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention