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 Corneal Edema (1791); Inflammation (1932); Irritation (1941); Keratitis (1944); Red Eye(s) (2038); Corneal Infiltrates (2231); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On 23nov2018 a patient (pt) in (b)(6) reported eye inflammation and was diagnosed with keratitis while wearing the 1-day acuvue define with lacreon brand contact lenses.The eye care provider (ecp) advised the pt not to wear lenses.The pt was prescribed levofloxacin ¿more than 3 times a day¿ but the eye is fine now.Pt thinks the event is due to ¿excess print¿.On 26nov2018 a call was placed to the pt and additional information was provided: the ecp advised the pt to only wear glasses now.The medical report was requested.The event date is reported as (b)(6) 2018.On 06dec2018 the pt¿s medical report was received: date of visit: (b)(6) 2018.Chief complaint: the od was red for 5 days.History: the pt had red eye after wearing contact lens.Pt was diagnosed with keratitis at a hospital and prescribed levofloxacin eye drops, acyclovir eye drops and ganciclovir ointment.Exam od: temporal bulbar conjunctival was ¿hyperaemia¿; ¿there was a white cloudy localized infiltrating lesion in the lower temporal position of the cornea, accompanied by edema¿.Diagnosis: od keratitis.Prescription: sodium hyaluronate eye drops, 1 bottle, od qid; levofloxacin ointment, 1 bottle, od.Notes: follow-up visit after 5 days; stop wearing contact lens; any discomfort, immediately go to the hospital.On 07dec2018 a call was placed to the pt who reported the symptoms have resolved and the pt is currently wearing spectacles.The pt reported possible lasik surgery as pt was told by ecp to avoid wearing contact lenses.On 12dec2018 a call was placed to the pt who reported a ¿few follow-up visits¿ to the ecp.Pt will try to get copies of the medical reports.On 24dec2018 the pts medical report was received: chief complaints: follow-up visit.¿eye exam: conjunctiva injection, od temporal; 8 o¿clock od corneal white encroaching opacity with edema¿.Diagnosis: keratitis od.Management: routine eye exam; once; anterior segment depth measurement; once; 5ml, 1 bottle, recombinant bovine basic fibroblast growth factor eye drops, qid, 0.05ml every time.No additional medical information has 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 3330590104 was produced under normal conditions.Two open lenses were received in a lens case.The parameters of the two open lenses were measured and a visual inspection was performed.The lenses met company standards for base curve, center thickness, and diameter.A magnified visual inspection revealed both lenses had an edge chip, excess lens material and excess color print.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: 8256775
• MDR Text Key: 133348913
• Report Number: 9617710-2019-00002
• 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: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/01/2022
• Device Catalogue Number: 1DL
• Device Lot Number: 3330590104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2018
• Date Manufacturer Received: 12/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention