MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. ¿ US 1-DAY ACUVUE MOIST; LENSES, SOFT CONTACT, DAILY WEAR

Catalog Number 1DM

Device Problem No Apparent Adverse Event (3189)

Patient Problems Bacterial Infection (1735); Corneal Ulcer (1796); Keratitis (1944); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2017, our affiliate in (b)(4) received a call from a patient¿s (pt) family member reporting the pt presented to an eye care provider (ecp) and was diagnosed with a ¿bacterial infection on eye¿ while wearing 1 day acuvue moist contact lenses in (b)(6) 2017.No additional medical information was provided.On (b)(6) 2017, a call was placed to the pt¿s family member and the additional information was provided: pt experienced sore eyes 3-4 weeks ago.Pt self-diagnosed a corneal ulcer on the internet and purchased over-the-counter drops at the pharmacy.Pt¿s symptoms subsided, but the ¿soreness came back.¿ pt went to a doctor for evaluation and was then referred to an ecp.The ecp diagnosed the pt with a corneal ulcer and ¿residual scarring.¿ ecp prescribed the pt medication (name and details of the treatment were unknown).Pt discarded the suspect lenses.On 07nov2017 a medical discharge form was received from the affiliate with the following additional information: date of discharge: (b)(6) 2017; condition at discharge: well; primary diagnosis: contact lens over-wear; discharge medications: fluorometholone (fml) 0.1% eye drop 1 gutt q.I.D; g cravit qds re; tears naturale p/free eye drop 1 gutt q.2.H.As needed (dry eye).No additional medical information was provided.On (b)(6) 2017 a medical report was received from the affiliate and the additional information was provided: date of visit: (b)(6) 2017.Follow-up for right eye marginal keratitis.Pt received treatment with po doxycycline, topical fml, topical cravat and dura tears ointment.Pt is responding to treatment and will continue to receive follow-up.Additional information was requested.No additional information was received.The lot number is unknown and the suspect product was discarded.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: 1-DAY ACUVUE MOIST
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE, INC. ¿ US; 7500 centurion parkway; jacksonville FL
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433364
• MDR Report Key: 7038368
• MDR Text Key: 92288159
• Report Number: 1057985-2017-00130
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: N18033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/23/2017

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: 1DM
• Device Lot Number: UNK-1DM
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/23/2017
• Initial Date FDA Received: 11/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 16