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 Corneal Ulcer (1796); Foreign Body Sensation in Eye (1869); Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2018, a representative from an (b)(6) office in (b)(6) called to report that a patient (pt) wearing 1-day acuvue trueye brand contact lens (cls) was diagnosed with a corneal ulcer in the right eye (od).The representative reported the pt has regularly visited the (b)(6) since (b)(6) 2017 for a prior diagnosis.Additional medical information was not provided.On (b)(6) 2018, the pt provided the following information: in (b)(6) 2018 the pt experienced foreign body sensation while wearing 1-day acuvue trueye cls.The pt removed the lens from the od, but the symptoms persisted.In (b)(6) 2018, the patient visited the (b)(6) and was diagnosed with staining od.The pt was instructed at that time to discontinue cl wear for a month and to return to the clinic (unspecified date).The pt was prescribed tobracin (tobramycin) and cravit (levofloxacin) eye drops.On (b)(6) 2018, the pt returned to the clinic and was instructed to discontinue the prescribed eye drops after using them.Multiple attempts to contact the ecp to verify the diagnosis and treatment were unsuccessful.The suspect product was discarded.No product or lot information was available.No analysis could be conducted.If additional information is received, will report within 30 days of receipt.Serious reportable event trends are reviewed quarterly in franchise management review meetings.

Manufacturer Narrative

On (b)(6) 2018, the patient¿s (pt) medical records were received from the treating eye care provider (ecp): on (b)(6) 2018, the pt was seen at the clinic with a chief complaint of ¿glare¿ and was diagnosed with an ¿infected¿ corneal ulcer approximately 1mm in size in the right eye (od).A culture was taken but there were no results.It was noted that the ulcer had no influence on the visual acuity; corrected visual acuity (va): od 1.2; uncorrected va: od 0.07; treatment: cravit (levofloxacine) eye drops 1.5%, tobracin (tobramycin) eye drops, and ecolicin (erythromycin lactobionate) eye cream; the pt was instructed to discontinue cl wear.On (b)(6) 2018, the pt returned to the clinic: ¿outcome: flat; tendency to improvement in photophobia.¿ on (b)(6) 2018, the pt returned to clinic: ¿outcome: tendency to resolving.¿ on (b)(6) 2018, the pt returned to clinic: ¿outcome: epithelization.¿ on (b)(6) 2018, pt returned to clinic.¿outcome: resolving; va: od 1.2." on (b)(6) 2018, an ecp representative was contacted and confirmed that the pt was advised to return for a follow-up visit within a month, however the pt had not returned to the clinic since (b)(6) 2018.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.Evaluation codes: code 1930 - infection.

Manufacturer Narrative

On (b)(6) 2018 a representative from the eye care provider¿s (ecp) office called with additional medical information: in (b)(6)2018 the patient (pt) reported os eye pain which persisted after the suspect lens was removed.On (b)(6) 2018 the pt presented to the ecp¿s office and was diagnosed with a corneal ulcer.Contact lens wear was discontinued until the symptoms resolved.The pt was prescribed cravit eye drops (levofloxacin), tobracin eye drops (tobramycin) and ¿cojicin¿ ophthalmic ointment.On (b)(6) 2018 the pt returned to the ecp and the pt was advised to continue no contact lens wear.On (b)(6) 2018 the pt returned to the ecp for a follow-up visit and was cleared to return to contact lens wear.No return visit to the ecp was instructed.On (b)(6) 2018 a call was received from the ecp¿s office with the lot number of the suspect product.No additional information was provided.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 5632470105 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: 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 FL ; EI
• MDR Report Key: 7523655
• MDR Text Key: 108606622
• Report Number: 1057985-2018-00073
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): Y
• PMA/PMN Number: K073485
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup,Followup
• Report Date: 11/07/2018

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 Expiration Date: 10/01/2022
• Device Catalogue Number: 1D4
• Device Lot Number: 5632470105
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/24/2018
• Initial Date FDA Received: 05/17/2018
• Supplement Dates Manufacturer Received: 05/28/2018; 11/07/2018
• Supplement Dates FDA Received: 06/22/2018; 11/30/2018
• Patient Sequence Number: 1
• Treatment: UNK.
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 35 YR