MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE ¿ IRELAND 1-DAY ACUVUE DEFINE WITH LACREON; LENSES, SOFT CONTACT, DAILY WEAR

Catalog Number 1DL

Device Problem No Apparent Adverse Event (3189)

Patient Problems Bacterial Infection (1735); Keratitis (1944); Pain (1994); Red Eye(s) (2038)

Event Date 09/11/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On 14sep2017 our affiliate in (b)(4) received a call from an eye care provider (ecp) who reported he/she received an e-mail from a patient (pt) who was diagnosed with corneal staining on (b)(6) 2017.The ecp provided the pts contact information and requested a call to follow-up with the pt for additional information.A call was placed to the pt for additional information to be sent via email.On (b)(6) 2017 the pt sent an email and provided additional information: pt inserted the suspect 1-day acuvue define with lacreon brand contact lens in the left eye without noticing the suspect lens was chipped.Pt reported he/she could not open the left eye and experienced severe photophobia and eye pain.Pt reported he/she would send the photo files of the diagnosis.On (b)(6) 2017 an email was received from the pt who provided images of the following: receipt from eye clinic dated: (b)(6) 2017; receipt of medical expense statement dated: (b)(6) 2017 - eye exam; treatment: application: 0.4 g ofloxacin 0.3% eye cream; eye patch; receipt from pharmacy dated: (b)(6) 2017; photo image of any eye; photo image of the blister packages; photo image of a contact lens on a fingertip.On (b)(6) 2017 a call was placed to the pt and additional information was obtained as follows: pt stated the os event is ¿pretty much resolved with remaining slight pain¿; pt went to eye clinic on (b)(6) 2017 and was diagnosed with corneal staining in the os; cefmenoxime hydrochloride 5 mg eye drops and ofloxacin eye ointment were prescribed (6id respectively); pt returned to clinic on (b)(6) 2017.On 20sep2017 the pt was prescribed another eye drops of which name is unknown; pt was instructed to discontinue the cl wear for 3- 4 days and instructed to return to the doctor if pt had pain.Pt agreed to medical interview.On 22sep2017 the medical interview was held by phone with the pts treating ecp and additional information was provided as follows: the patient (pt) was diagnosed as keratitis (with bad red eye overall); corneal staining was located on the ear side of os, off pupil; ecp reported it was infective and va not affected; pt was prescribed cefmenoxime hydrochloride 0.5% eye drops and ofloxacin 0.3% eye ointment were prescribed (6id respectively).On (b)(6) 2017 the ecp switched prescription to levofloxacin eye drops; on (b)(6) 2017, last visit, no return to clinic was instructed; pt had a good outcome and recovered.On 28sep2017 an email was sent to the pt for follow-up, but no additional information has been received.The suspect product was requested for return for evaluation, but it has not been received.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 3427300661 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 DEFINE WITH LACREON
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE ¿ IRELAND; one technological park plassey; limerick ; EI
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433364
• MDR Report Key: 6952313
• MDR Text Key: 89412987
• Report Number: 9617710-2017-05047
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: N18033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 09/20/2017

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: 05/01/2021
• Device Catalogue Number: 1DL
• Device Lot Number: 3427300661
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/20/2017
• Initial Date FDA Received: 10/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2016
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 32