MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. ¿ IRELAND 1-DAY ACUVUE TRUEYE (NARA A); LENSES, SOFT CONTACT, DAILY WEAR

Catalog Number 1D4

Device Problem No Apparent Adverse Event (3189)

Patient Problems Bacterial Infection (1735); Corneal Ulcer (1796); Pain (1994); Red Eye(s) (2038); Excessive Tear Production (2235)

Event Date 07/27/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6.

Event Description

On (b)(6) 2017 our affiliate in (b)(6) received a complaint from a patient (pt) who reported while wearing the 1-day acuvue trueye brand contact lenses, he/she had an ¿eye injury caused by the hardness of the lens¿ and wanted to return the lenses.On (b)(6) 2017 a call was placed to the pt and additional information was provided as follows: pt reported he/she used to wear glasses, but started to use the lenses every day about a month prior.The pt reported right eye pain before removing the suspect lens (date of the event was not provided).After removal of the suspect lens the pt experienced tearing that would not stop, eye pain, and red eye.The pt reported he/she went to an ecp the following day due to the eye pain, around the end of (b)(6).The pt reported the ecp advised the pt ¿such staining would not occur with normal contact lens usage and that the hardness of the contact lens might be the cause¿.The pt was prescribed levofloxacin and an additional eye drop (name of the medication was not provided) and instructed to return to the ecp every other week.Pt was instructed to discontinue contact lens use and reports restarting lens wear on (b)(6) 2017 per ecp instruction.The pt now uses ¿softer contact lenses" and will not use the 1-day acuvue trueye lenses.The pt reported the od was currently fine with a ¿little scar¿ remaining that may be permanent.The pt agreed to a medical interview.On (b)(6) 2017 a call was placed to the pts treating ecp and a representative provided additional information: the representative reported the pt was wearing 1-day acuvue trueye and complained of red eye and sharp pain in right eye since before going to bed on (b)(6) 2017.The visited the ecp the next day on (b)(6) 2017.The pt was diagnosed with corneal ulcer in upper peripheral part of od, at around 11:50 ¿ 12:00, off the pupil, and prescribed one bottle each of levofloxacin 1.5% and cefmenoxime hydrochloride eye drops for od, qid.Infectiveness and culture were not investigated.Pt returned to the clinic on (b)(6) , (b)(6) , and (b)(6) 2017.A medical interview with the pts treating ecp who was scheduled (b)(6) 2017.On (b)(6) 2017 a medical interview was held and additional information was provided: the pts first visit was (b)(6) 2017; the pt was diagnosed with corneal ulcer in peripheral part of od at 12:00, off the pupil.A culture was not conducted, but the ecp assumed it was infectious; visual acuity (va) was not affected; the corrected va was 1.2.; pt was prescribed levofloxacin 1.5% eyedrops, cefmenoxime hydrochloride 0.5% eyedrops were prescribed (qid.); pt returned to the clinic on (b)(6) 2017 and (b)(6) 2017; the last pt visit was (b)(6) 2017, the event resolved and the pt was prescribed the 1-day acuvue moist brand contact lenses.The pt was prescribed levofloxacin 1.5% eyedrops was prescribed to apply bid for the rest of (b)(6) 2017; the ecp also reported the pt had a slight ptosis which could cause the symptoms.On (b)(6) 2017 a medical interview was held with the ecp who provided additional information: on (b)(6) 2017, the pt returned to the hospital and the od was resolved without permanent damage, although a slight scar remained in peripheral part of od.No additional medical information has been received.The pt reported the suspect product was discarded.A lot history review was performed for lot 5827480111: 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 5827480111 was produced under normal conditions.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 TRUEYE (NARA A)
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• 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: 6869504
• MDR Text Key: 86337859
• Report Number: 9617710-2017-05043
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K073485
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/25/2017

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 Expiration Date: 05/01/2022
• Device Catalogue Number: 1D4
• Device Lot Number: 5827480111
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/25/2017
• Initial Date FDA Received: 09/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2017
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention