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

Catalog Number AVG

Device Problem No Apparent Adverse Event (3189)

Patient Problem Acanthameba Keratitis (1945)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2018, an email was received from an eye care professional (ecp).The email contained an attached summary data spreadsheet containing the medical information for subjects involved in the study of acanthamoeba keratitis conducted in the uk.The information received from the ecp included only those study subjects who reported wearing acuvue brand products at the time of the adverse event.All the study subjects were initially examined and diagnosed with acanthamoeba keratitis during 2011-2014.The patient (pt), (b)(6), initially diagnosed with herpes simplex virus keratitis (hsv).The pt was referred to the hospital on (b)(6) 2013 and was diagnosed with acanthamoeba keratitis od.Pt reported wearing the acuvue advance brand contact lenses and used an unknown solution brand.Pt reported lasik 20 years prior.Pt reported the contact lens case was 1 year old, rinsed with water and pt showered in lenses.Pt was treated with antiamoebics 8 months, topical steroid after diagnosis; mycophenolate, iatraconazole.Va: hand motion.No additional information is expected to be received.The lot number of the suspect product is unknown.Suspect product is not available for return for evaluation.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: ACUVUE ADVANCE
• 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: 7436094
• MDR Text Key: 105667577
• Report Number: 1057985-2018-00056
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K032340
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/23/2018

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: AVG
• Device Lot Number: UNK-AVG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/23/2018
• Initial Date FDA Received: 04/17/2018
• 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: 45