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 Keratitis (1944); Pain (1994); Blurred Vision (2137); Discomfort (2330)

Event Date 06/21/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2019, an email was received from an eye care provider (ecp) in (b)(6) reporting that a patient (pt) was diagnosed with keratitis after wearing a 1-day acuvue® define¿ with lacreon® brand contact lens (cl).On (b)(6) 2019, additional information was received from the pt: the pt experienced discomfort in the right eye (od) after a few hours of wearing the cl on (b)(6) 2019.The pt experienced ¿central vision defect¿ after cl removal.The pt described the symptom as ¿seeing a black spot in middle of her vision¿.The pt visited an ecp and was diagnosed with ¿corneal epithelial injury¿.The pt reported that there was no diagnosis of ¿keratitis¿.The pt was prescribed eye drops but was not able to provide any further information.The pt reported that the od currently feels painful but is getting better.On (b)(6) 2019, additional information was received from the pt: the pt reported that the od is much better now.No further medical information was provided.Multiple attempts were made to obtain the pt¿s medical report and additional medical information.No additional information has been received.This event is being reported as a worst-case event as the diagnosis and treatment were unable to be verified.The suspect od cl 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 2443990102 was produced under normal conditions.If any further relevant information is received, a supplemental report will be filed.

Manufacturer Narrative

On 07aug2019, a medical report dated (b)(6) 2019 and prescription document dated (b)(6) 2019 was received from the patient (pt): initial visit record: chief complaint: ¿dim and blurry vision right eye (od); near vision good od.¿ present and past medical history: history of od pain.Physical examination: ¿(+) conjunctiva congestion od, cornea: (+) small central area epithelium defect, clear elsewhere, ac(-), the crystalline lens clear, fundus ?(not recognizable), c/d 0.4.¿ diagnosis: corneal epithelial defect od.Treatment: ofloxacin ×1 tid od; calf serum ×1 tid od; follow up in 1 week.Prescription document: levofloxacin eye drops (ofloxacin), drip into the eyes tid, one drop at a time; calf blood deproteinized extract ophthalmic gel, spread into the eyes tid, two drops at a time.If any further relevant information is received, a supplemental report will be filed.Section h.6.Evaluation codes: code 2137 - blurred vision.

• 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
• MDR Report Key: 8802011
• MDR Text Key: 151438634
• Report Number: 9617710-2019-00025
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): Y
• PMA/PMN Number: N18033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 08/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/01/2022
• Device Catalogue Number: 1DL
• Device Lot Number: 2443990102
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/07/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention