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 Foreign Body Sensation in Eye (1869); Unspecified Infection (1930); Red Eye(s) (2038)

Event Date 11/08/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2017 a patient in (b)(6) called our affiliate to report a foreign body sensation in the right eye while wearing the 1-day acuvue trueye brand contact lenses.The pt removed the suspect contact lens and noted the edge was chipped.Pt reported persisting redness after the suspect lens was removed.On (b)(6) 2017 a call was placed to the pt and additional information was provided: on (b)(6) 2017 the pt went to an eye care provider (ecp) and was diagnosed with a ¿superficial injury of the eye in od¿.Eye drops were prescribed (names were not known).Pt was advised to return to the clinic if the symptoms did not resolve.On 24nov2017 medical receipts were received from the pt for dates of visit: (b)(6) 2017, however no medical information was provided.Also 3 receipts were received from a pharmacy dated (b)(6) 2017.On 08dec2017 a call was placed to the pts treating ecp for a medical interview and a representative at the ecp¿s office provided additional information: "diagnosis: corneal infection; focal site: od; it was located where va was not affected.Infectiveness: (y); influence on visual acuity: na; course of treatment: date of doctor visit by the pt: (b)(6) 2017 (5 visits); levofloxacin 1.5% eye drops qid od was prescribed.The pt was instructed to return to clinic frequently as pt¿s eye had staining and infection and the staining was not well resolved.The pt returned to clinic on (b)(6) 2017 for prescription issuance as pt was worried about using up the eye drops.Pt¿s recovery was confirmed by the doctor on 21nov2017¿.No additional medical information has been received, no additional medical information is expected.The suspect od contact lens was discarded.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 5628060102 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: 7152290
• MDR Text Key: 96005524
• Report Number: 9617710-2017-05080
• 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: 12/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/01/2022
• Device Catalogue Number: 1D4
• Device Lot Number: 5628060102
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2017
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 54