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

Catalog Number 1DL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Foreign Body Sensation in Eye (1869); Itching Sensation (1943); Keratitis (1944); Discomfort (2330)

Event Date 01/06/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2019, an eye care provider (ecp) from (b)(6) reported that a patient (pt) experienced discomfort after insertion of 1-day acuvue® define¿ with lacreon® brand contact lenses (cl).On (b)(6) 2019, additional information was received from the pt: the pt reported experiencing discomfort in the right eye (od) after a few hours of cl wear on (b)(6) 2019.The pt still felt discomfort od after removal of the cl.The pt visited an ophthalmologist on (b)(6) 2019 and was diagnosed with keratitis.Two eye drops were prescribed: ganciclovir eye drops and levofloxacin hydrochloride eye drops, once every 2 hours.The pt is currently experiencing itchiness and still being able to ¿feel something¿ in the od.The pt was not able to provide a medical report.On (b)(6) 2019, additional information was received from the pt: the pt reported the od was better but still dry.The pt did not return to see the ophthalmologist.The pt is currently still using the same previously prescribed eye drops.No additional information has been received.The suspect cl is not available for return.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 3332160104 was produced under normal conditions.If any further relevant information is received, a supplemental report will be filed.

• Brand Name: 1-DAY ACUVUE DEFINE WITH LACREON
• 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: 8294520
• MDR Text Key: 134784845
• Report Number: 9617710-2019-00003
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: N18033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/01/2023
• Device Catalogue Number: 1DL
• Device Lot Number: 3332160104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention