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

Catalog Number 1DM

Device Problem No Apparent Adverse Event (3189)

Patient Problems Irritation (1941); Pain (1994); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2017 an email was received from a patient (pt) who reported while wearing the 1-day acuvue moist brand contact lenses one eye (affected eye was not provided) became ¿extremely irritated¿.The pt reported wearing the lens brand for many years without issue.The pt reported ¿i had to stop wearing contacts figuring it would resolve¿.The pt went to an eye care provider (ecp) and was advised there was ¿scar tissue¿ but no known cause.Pt reported the event resolved and was able to resume contact lens wear after switching to a different ¿batch¿ of the same brand and all was well.Pt reported he/she resumed using the same brand and reports now both eyes hurt and pt gets relief when the lenses are removed.Pt stated he/she can ¿physically feel a gritty texture on the lenses from this lot! it is like they are coated in plastic.¿ pt reported while wearing the lenses he/she experiences pain and discomfort.Pt reported eyes are still hurting and will have to return to the ecp.No additional information was received.Multiple attempts were made to contact the pt for additional information, but nothing additional has been received.The date of the event was not provided.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 2741990106 was produced under normal conditions.It is unknown if the suspect lens is available for return.If additional information is received it will be reported within 30 days of receipt.Serious reportable event trends are reviewed quarterly in franchise management review meetings.

• Brand Name: 1-DAY ACUVUE MOIST
• 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: 7143716
• MDR Text Key: 95926160
• Report Number: 9617710-2017-05079
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N18033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/01/2022
• Device Catalogue Number: 1DM
• Device Lot Number: 2741990106
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/30/2017
• Initial Date FDA Received: 12/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2017
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention