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

Catalog Number PH

Device Problem No Apparent Adverse Event (3189)

Patient Problems Acanthameba Keratitis (1945); Pain (1994); Red Eye(s) (2038)

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), presented to the hospital on (b)(6) 2013 experiencing moderate pain, severe redness and slight photophobia os where the pt was diagnosed with acanthamoeba keratitis.The pt reported wearing acuvue® oasys® brand contact lenses.The pt reported being on a on a long flight and removing lenses with wet hands.The pt also reported "decanting solution", using a case that was 1 year old and sleeping in lenses (2 nights per year, 1 night in a row).The pt was treated with antiamoebics for 2 months.The pt was treated with topical steroids after being diagnosed.Va: 6/36 (20/120) os.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 OASYS
• Type of Device: LENSES, SOFT CONTACT, EXTENDED 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: 7437644
• MDR Text Key: 105721994
• Report Number: 1057985-2018-00061
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P040045
• 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

• Date FDA Received: 04/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: PH
• Device Lot Number: UNK-PH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2018
• 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
• Treatment: BIOTRUE/RENU/TESCO BRAND SOLUTIONS
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 26