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 Keratitis (1944); Acanthameba Keratitis (1945); Pain (1994); Red Eye(s) (2038); Blurred Vision (2137); Loss of Vision (2139); Excessive Tear Production (2235)

Event Type  Injury  

Manufacturer Narrative

Report source: 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 23 march 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), study id 47, was initially diagnosed with hsv keratitis after experiencing severe pain, photophobia, redness, watery eye with poor vision od.The pt was treated with topical steroids for six months prior to being referred to the hospital on (b)(6) 2011 where the pt was diagnosed with acanthamoeba keratitis od.The pt reported wearing 1 day acuvue brand contact lenses.The reporting eye care professional indicated there were ¿no extenuating circumstances¿ prior to the pt developing symptoms.The pt was treated with antiamoebics for 2 years, 3 months and topical steroids od after being diagnosed.The pt subsequently developed glaucoma.Additional treatment included: superficial keratectomy, penetrating keratoplasty x2, cryotherapy, botox, gluing and enucleation of the od.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: 7426634
• MDR Text Key: 105372099
• Report Number: 1057985-2018-00042
• 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: 04/12/2018
• 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
• Patient Outcome(s): Hospitalization; Other; Required Intervention; Disability
• Patient Age: 9