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

Catalog Number 1DM

Device Problem No Apparent Adverse Event (3189)

Patient Problems Corneal Ulcer (1796); Pain (1994); Red Eye(s) (2038); Swelling (2091)

Event Date 12/08/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2017 our affiliate in (b)(4) received a report from the pharmaceuticals and medical devices agency (pmda) via fax.An eye care provider (ecp) reported on (b)(6) 2017 that a patient (pt) was diagnosed with a corneal ulcer in the left eye while wearing the 1-day acuvue moist brand contact lenses.The date of the event was reported as (b)(6) 2017.Pt reported to the clinic complaining of redness, pain and swelling.Pt was instructed to discontinue contact lens wear.A corneal curettage was performed and the pt wore a patch over left eye.Pt was prescribed cravit ophthalmic solution 0.5 % six times daily to the left eye.The pt was instructed to return to the clinic on (b)(6) 2017.The ecp reported that the pt ¿repeatedly bought contact lenses on internet for more than a year without seeking medical attention for contact lens prescription¿.On (b)(6) 2017 an email was received from a johnson and johnson sales representative who reported an interview with the reporting ecp is impossible.No additional information was provided and no additional medical information is expected.The lot number was not provided and 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. ¿ US; 7500 centurion parkway; jacksonville FL
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433364
• MDR Report Key: 7158355
• MDR Text Key: 96183570
• Report Number: 1057985-2018-00002
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: N18033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/11/2017

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 Catalogue Number: 1DM
• Device Lot Number: UNK-1DM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2017
• Initial Date FDA Received: 01/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 29