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 Uveitis (2122); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

Eval: no testing methods performed.No results available since no evaluation performed.Unable to confirm complaint.Device not returned.

Event Description

On (b)(6) 2018 a patient (pt) in (b)(6) reported discomfort in the left eye while inserting a 1-day acuvue moist brand contact lens in (b)(6) 2018.The pt reported the lens was worn about half the day and it was noted to be chipped on removal.The pt presented to the eye care provider (ecp) on (b)(6) 2018 and was diagnosed with staining and ¿incipient uveitis os¿.The pt was instructed to discontinue contact lens wear.Pt was prescribed mucosta ophthalmic suspension ud, hyalein ophthalmic solution and additional eye drops the pt was unable to recall.On (b)(6) 2018 the pt had a follow-up appointment and was not prescribed any eye drops.The pt refused to provide further information.On (b)(6) 2018 the pt consulted a different ecp and was diagnosed with staining and ¿incipient uveitis os¿.Pt was instructed to discontinue contact lens wear.Pt was given a return appointment for (b)(6) 2018, no medication was prescribed.The pt did not agree to a medical interview.The pt reported the staining is persisting and will not wear lenses.Pt has a follow-up visit with the ecp on (b)(6) 2018.On 19feb2018 a call was placed to the pt for additional medical information: the pt only reported he/she will continue to return to the clinic for follow-up.The pt refused to provide any additional information.No additional medical information is expected.The lot number is unknown and the suspect lens was discarded.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.

Manufacturer Narrative

On 27mar2018 during a file review it was noted that on the initial mdr the product was not labeled for single use.The product is labeled for single use.

• 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: 7332597
• MDR Text Key: 102192300
• Report Number: 1057985-2018-00029
• 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: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/27/2018

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?: No
• Initial Date Manufacturer Received: 02/14/2018
• Initial Date FDA Received: 03/12/2018
• Supplement Dates Manufacturer Received: 03/27/2018
• Supplement Dates FDA Received: 04/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention