MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE - IRELAND ACUVUE 2 DEFINE; LENSES, SOFT CONTACT, EXTENDED WEAR

Catalog Number A2D

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

Patient Problems Corneal Edema (1791); Corneal Scar (1793); Eye Injury (1845); Foreign Body Sensation in Eye (1869); Keratitis (1944); Red Eye(s) (2038); Visual Disturbances (2140); Excessive Tear Production (2235); Eye Pain (4467); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/07/2020

Event Type  Injury  

Manufacturer Narrative

Suspect product was discarded.

Event Description

On 15jul2020 a patient (pt) in (b)(6) called to report the eyes had not recovered from a (b)(6) 2020 event of eye pain, tearing and eye stinging while wearing the acuvue® 2® define¿ brand contact lens (cls).The pt reported seeing an eye specialist since (b)(6) 2020 for ¿corneal mechanical damage¿ that may lead to permanent scarring.On 21jul2020 the pt provided medical reports from the eye care provider (ecp) visits.Date of visit: (b)(6) 2020: od: 0.4; the corneal is clear, normal fundus and the boundary of the optic disc is clear/normal.Refraction exam performed; prescribed sodium hyaluronate eye drops tid.Date of visit: (b)(6) 2020: ¿subjective optometry od: -5.00 ds¿0.3¿; the od corneal epithelium is ¿rough¿, the anterior chamber is clear, light reflection is normal; diagnosis: corneal epithelial injury in the od.Prescribed recombinant human epidermal growth factor derivative eye drops and recombinant bovine basic fibroblast growth factor in eye drop; return visit in a week.Date of visit: (b)(6) 2020: the patient could not see clearly in the right eye (may); history of wearing contact lenses; diagnosis: ¿corneal epithelium edema above the right eye¿; prescribed: 0.02% fluorometholone eye drops, 1 drop twice a day for right eye; sodium hyaluronate eye drops, 1 drop three times a day; deproteinized calf blood extract eye gel, 2 drops, three times a day; follow-up review.Date of visit: (b)(6) 020: pt used soft contact lenses; diagnosis: upper corneal epithelial staining; prescribed: 0.02% fluorometholone eye drops, one drop three a day; levofloxacin eye drops, one drop three times a day; follow-up review.On 21jul2020 the pt provided additional information.The pt had a return ecp visit on (b)(6) 2020.The pt is currently using bandage cls, (affected eye not provided).The pt reported ¿there may be surgery if the od does not become better.¿ the pt is currently using fluorometholone drops od tid and another eye drop that contains ¿polyethylene glycol¿ ou tid.The pt is to return for a follow-up visit in 2 weeks.On 11aug2020 the pt provided additional information.The pt had a return ecp visit on (b)(6) 2020.Pt still using same eye drops as previously prescribed on (b)(6) 2020.The eyes are still not fully recovered.The pt has a return ecp visit at end of (b)(6) 2020.On (b)(6) 2020 a call was placed to the pt who reported a return ecp visit one week ago.The ecp advised the pt that the cornea is recovering well, but the event was not fully resolved.The pt is to return to the ecp at the end of september and will provide additional medical reports.On 09sep2020 the pts complaint was assessed for regulatory reportability and determined to be not a reportable serious event to the us fda or (b)(6) competent authorities.On 08may2021 additional medical information was received from the pt.Date of visit: (b)(6) 2020: additional information provided.Patient history: the patient could not see clearly in the right eye (unreadable ¿(b)(6) or 5 months?¿) exam: ¿corneal epithelium edema above the right eye.Od: tyn(-); lens (-).Diagnosis: binocular keratitis od.Prescribed: 0.02% fluorometholone eye drops twice a day for od; sodium hyaluronate eye drops, qid od; deproteinized calf blood extract eye gel qid od; follow-up review.Date of visit: (b)(6) 2020: handwriting of rx and exam are unreadable.Prescribed: 0.02% fluorometholone eye drops 1 box; levofloxacin eye drops 1 box.¿wear cls in od.¿ 2nd ecp visit on 0(b)(6) 2020: history: follow-up review ophthalmology; the patient feels better; examination: hyperemia is reduced; the upper corneal epithelium is spotted staining.The ¿rest are normal¿.Consultation with corneal specialist; follow-up review.Date of visit: (b)(6) 2020; exam: conjunctival hyperemia of the right eye is reduced, caligo corneae (corneal opacity due to scarring).Prescribed: ophthalmic anterior segment imaging; 0.02% fluorometholone eye drops 1 box; polyethylene glycol eye drops.Additional information is unreadable.Due to the additional medical information of od diagnosis of ¿caligo corneae¿ received on 08may2021, this event was determined to be a reportable serious event to the us fda and the (b)(6) competent authorities.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 3634820101 was produced under normal conditions.The suspect od discarded.No additional evaluation can be conducted.If any further relevant information is received, a supplemental report will be filed.

• Brand Name: ACUVUE 2 DEFINE
• Type of Device: LENSES, SOFT CONTACT, EXTENDED WEAR
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE - IRELAND; 1 technological park plassey; limerick LK130 01; EI LK13001
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433647
• MDR Report Key: 11922939
• MDR Text Key: 253865875
• Report Number: 9617710-2021-00112
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• 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,health profe
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/01/2024
• Device Catalogue Number: A2D
• Device Lot Number: 3634820101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention