MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. ¿ IRELAND ACUVUE 2; LENSES, SOFT CONTACT, EXTENDED WEAR

Catalog Number AV2

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

Patient Problems Bacterial Infection (1735); Conjunctivitis (1784); Irritation (1941)

Event Date 12/30/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2019 a patient (pt) in (b)(6) called to report after 2 hours of use, 4 lenses ou were blurry while wearing the acuvue® 2® brand contact lenses (cls).The pt needed to ¿keep instilling eye drops all day (name of eyedrop not provided).¿ the pt reported the lenses were purchased without a prescription.On 14jan2020 a call was placed to the pt who provided additional information: the pt went to an eye care provider (ecp) on (b)(6) 2020 who advised the eyes were irritated and diagnosed bacterial conjunctivitis in the od only.The ecp prescribed an eyedrop (name of eyedrop unknown) and advised the pt to suspend cls use for 30 days.The pt clarified the (b)(6) 2019 information as, when the lenses were blurry, the lenses were ¿sticky¿ and caused irritation on both eyes.The pt believes the cls solution, limplent caused the irritation.The pt reported daily lens wear with a monthly replacement schedule.On (b)(6) 2019 the pt provided an image of the prescription bottle, cilodex (ciprofloxacin/dexamethasone).A call was placed to the pts treating ecp office and a representative reported the ecp will be back in the office on saturday.The representative reported the pt initially visited the ecp on (b)(6) 2020 and was provided 2 prescriptions but could not read the ecp¿s additional notation on the pt chart.On 17jan2020 a call was placed to the pt who reported the cilodex was prescribed every 3 hours until the return visit ecp in 1 week.The pt was also advised to discontinue cls wear for 30 days.The pt was advised that the ecp diagnosed bacterial conjunctivitis od.The pt has not been back to the ecp for a return visit but will schedule a visit soon.The pt reported the od was better after 1-2 days of using the prescribed medication.The returned to cls wear yesterday without the return of symptoms.On 21jan2020 a call was placed to the pts treating ecp who reported the pt was diagnosed with bacterial conjunctivitis od and prescribed cilodex q 3 hours for 8 days.The pt returned to the ecp on saturday to verify prescription for eye glasses.The pt¿s eyes were ok, no additional treatment was provided.The pt was advised not to wear cls for 15 day, then ok to return to cls wear.The ecp reported the problem is with the pts ¿hygiene¿, not the cls.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 l003zpc was produced under normal conditions.The suspect od contact lens was discarded.No additional investigation can be conducted.If any further relevant information is received, a supplemental report will be filed.

• Brand Name: ACUVUE 2
• Type of Device: LENSES, SOFT CONTACT, EXTENDED 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: 9672352
• MDR Text Key: 189496344
• Report Number: 9617710-2020-00007
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): Y
• Reporter Country Code: BR
• 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
• Type of Report: Initial
• Report Date: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: AV2
• Device Lot Number: L003ZPC
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 31 YR