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

Catalog Number 1D2

Device Problem No Apparent Adverse Event (3189)

Patient Problems Foreign Body Sensation in Eye (1869); Keratitis (1944); Acanthameba Keratitis (1945)

Event Type  Injury  

Manufacturer Narrative

Nicole carnt, jeremy hoffman, seema verma, cherry radford, darwin c.Minassian and john k.G.Dart: acanthamoeba keratitis: confirmation of a current uk outbreak and a prospective case control study identifying contributing risk factors.(b)(4).

Event Description

On (b)(6) 2018, an email was received from an eye care professional (ecp).The ecp is the author of a prospective study, conducted in the uk, that has been submitted for publication in 2018.The email contained an attached summary data spreadsheet containing the medical information for subjects involved in the prospective acanthamoeba keratitis study.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) was initially diagnosed with hsv keratitis after experiencing mild foreign body sensation os.The pt was treated with topical steroids prior to being referred to the hospital on (b)(6) 2013 where the pt was diagnosed with acanthamoeba keratitis.The pt reported wearing 1 day acuvue brand contact lenses.The daily lenses worn by the pt were two months old at the time of the event.The pt reported the current case was 3 years old, topped off the solution in the case and rinsed the lenses with tap water prior to using a multipurpose solution.The pt was treated with antiamoebics for 8 months and topical steroids after being diagnosed.The pt was admitted to the hospital 9 times.The pt subsequently developed glaucoma.Additional treatment included: intensive rx, corneal biopsy, automated lamellar keratoplasty (alk), 3x injection of gas, 2x posterior dmek keratoplasty, cataract extraction and intraocular lens (iol).Final va 6/36 (20/125) 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: 1-DAY ACUVUE
• 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: 7429368
• MDR Text Key: 105438590
• Report Number: 1057985-2018-00045
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: N18033
• 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: 1D2
• Device Lot Number: UNK-1D2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/23/2018
• Initial Date FDA Received: 04/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: COMPLETE MULTI PURPOSE SOLUTION
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 60