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

Catalog Number 1MA

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

Patient Problem Red Eye(s) (2038)

Event Date 09/03/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On 12nov2019 an email was received from an eye care provider (ecp) in spain who reported a patient (pt) experienced ¿damage¿ to the cornea while wearing the 1-day acuvue® moist® for astigmatism brand contact lenses.On 12nov2019 a call was placed to the reporting ecp who provided additional information: the ecp reported a family member reported the pt was ¿never really careful with the contact lenses¿ and used to wear the lenses for ¿way too long even though the pt was advised not to.¿ no additional medical information was provided.On 22nov2019 the ecp provided additional medical information: the date of event was (b)(6) 2019; diagnosis: corneal opacities and hyperemia.On 28nov2019 the ecp provided additional medical information: the pts treating ophthalmologist diagnosed opacities and hyperemia ou.It is unknown if the event has resolved.No additional medical information is known.The suspect od contact lens was discarded.No additional evaluation can be completed.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 3136970101 was produced under normal conditions.This report is for the pts od event.The event for the pts os will be submitted in a separate report.If any further relevant information is received, a supplemental report will be filed.

• Brand Name: 1-DAY ACUVUE MOIST FOR ASTIGMATISM
• 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: 9468066
• MDR Text Key: 187536986
• Report Number: 9617710-2019-00051
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): Y
• Reporter Country Code: SP
• PMA/PMN Number: N18033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/01/2024
• Device Catalogue Number: 1MA
• Device Lot Number: 3136970101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 16