MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION . ¿ 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); Conjunctivitis (1784); Red Eye(s) (2038); Blurred Vision (2137); Discharge (2225); Discomfort (2330)

Event Date 07/24/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On 27jul2017 information was received by our affiliate in the (b)(6) from an eye care provider (ecp) who reported that a patient (pt) wearing the 1-day acuvue define brand contact lenses reported lenses causing ¿infection¿ on two occasions.On 28jul2017 a call was placed to the pts reporting ecp; a representative provided additional information: the representative reported two separate ¿eye infections¿ on (b)64) 2017; symptoms included: infection, redness, discharge and advised the pt experienced blurry vision afterward; the pt was prescribed eye drops every two hours, but did not have the name of the medication; both eyes were affected; the lot number was not known at the time.On 02aug2017 additional information was received from our affiliate in the united kingdom: a call was placed to the pts reporting ecp by a johnson and johnson (b)(4) physician for additional medical information: a representative at the ecp¿s office reported that the pt only purchased the lenses from the office and have not done an eye exam on the pt.-history: on (b)(6) 2017 the pt returned to contact lens wear; after four hours she experienced discomfort, redness and a little discharge, again both eyes affected; pt attended the pharmacy and was given antibacterial drops (no name given) to use every 2 hours.Vision seemed more blurry in left eye compared to right; not known how long drops were used for.On (b)(6) 2017, the pt returned to optician who has confirmed that vision is fine and eyes healthy; pt may re-start lens wear; pt is not a new contact lens wearer and has reported has not reported any prior issues.Per the johnson and johnson (b)(4) physician, the event ¿sounds like a case of bacterial conjunctivitis¿ given the relatively rapid onset, timescale and response to treatment.Additional medical information was requested.On 04aug2017 the johnson and johnson (b)(4) physician placed a call to the pt who reported the following additional information: on (b)(6) 2017 the pt inserted lenses at 7:45 am; after twenty minutes of lens wear both eyes felt uncomfortable within 20 minutes; both lenses removed and discarded; eyes red, uncomfortable and had sticky discharge; pt went to the pharmacy who issued optrex eye drop (chloramphenicol 0.5%) which pt continues to use 2 x daily;.Both eyes now white, comfortable and vision normal.On (b)(6) 2017 the pt went to an optician who confirmed the eyes were healthy and ok to return to contact lens wear.This report is for the pts od event dated (b)(6) 2017.A separate report will be submitted for the pts os (b)(6) 2017 event.The event is being submitted as a worst case event as the diagnosis and treatment were unable to be verified.A separate report will also be submitted for the second reported event on (b)(6) 2017.The 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 2330720102 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 . ¿ IRELAND; one technological park plassey; limerick ; UK
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433364
• MDR Report Key: 6803678
• MDR Text Key: 83034754
• Report Number: 9617710-2017-05031
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 07/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/01/2020
• Device Catalogue Number: 1DL
• Device Lot Number: 2330720102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2015
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention