MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. ¿ IRELAND ACUVUE OASYS1 DAY WITH HYDRALUXE TECHNOLOGY; LENSES, SOFT CONTACT

Catalog Number TSP

Device Problem No Apparent Adverse Event (3189)

Patient Problems Keratitis (1944); Pain (1994); Red Eye(s) (2038)

Event Date 05/30/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter¿s phone number: (b)(6).

Event Description

On (b)(6) 2018 a call was received from an eye care provider (ecp) in (b)(6) reported a patient (pt) was diagnosed with keratitis while wearing the trial lenses of acuvue oasys 1-day brand contact lenses (cl).On 13jun2018 additional information was received: -pt was diagnosed with keratitis os.The event date was reported as (b)(6) 2018.The pt went to the ecp on (b)(6) 2018 as an emergency referral.The pt was prescribed oftaquix every hour and tobrex ¿depot x2¿.¿cultivation should have been done, but i have no reply to this¿.The pt went to an ophthalmologist and it was noted the eye healed well.Lens rest for 3 weeks as requested by the doctor, then ¿start use carefully¿.It was unknown if the pt had any corneal scarring.On (b)(6) 2018 additional information was received from the pt's ecp: -additional information from the treating ophthalmologist: pt was diagnosed with keratitis; the visual acuity was not affected; symptoms included sudden pain and photophobia os after wearing the cls for the day (20/20 vision at after care in os).The ecp does not know if the pt rinsed the lenses in any solution before insertion or ¿when the lenses were in the eye.¿ no additional medical information was provided.On 20jun2018 a translation was received of the incident report from the (b)(4) dates (b)(6) 2018, no report number was provided.-translation: ¿the (b)(6) enters the store for a booked contact lens aftercare.Pt then mention that the pt experienced pain in the left eye for two days ago.The pain was sudden in the evening after a full day of contact lens wear.(b)(6) experience photophobia and eye redness.Referral to the eye emergency due to suspected keratitis; keratitis left eye; experienced contact lens wearer who earlier used monthly lenses without any issues.(b)(6) works outside and gets easily gravel into the eyes according to pt.(b)(4) received an urgent referral to the eye department at the hospital in (b)(6).Were diagnosed with keratitis¿.The availability of the suspect lens is unknown.No additional medical or product information has been received.No additional information is expected.A lot history review was performed and revealed the following: the batch record did not show any abnormalities in monomer and solution testing.All parameters tested were within specification.All sterilization requirements were successfully completed.Lot 5533470105 was produced under normal conditions.If any further relevant information is received, a supplemental report will be filed.Serious reportable event trends are reviewed quarterly in franchise management review meetings.

• Brand Name: ACUVUE OASYS1 DAY WITH HYDRALUXE TECHNOLOGY
• Type of Device: LENSES, SOFT CONTACT
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE, INC. ¿ IRELAND; one technological park plassey; limerick ; EI
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433364
• MDR Report Key: 7660366
• MDR Text Key: 113161017
• Report Number: 9617710-2018-05041
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): Y
• Reporter Country Code: SW
• PMA/PMN Number: K042275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/01/2022
• Device Catalogue Number: TSP
• Device Lot Number: 5533470105
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/30/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention