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

Catalog Number 1D4

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

Patient Problems Corneal Scar (1793); Corneal Ulcer (1796); Foreign Body Sensation in Eye (1869); Pain (1994); Red Eye(s) (2038); Discomfort (2330)

Event Date 08/04/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2019 a patient¿s (pt) family member from (b)(6) called to report a diagnosis of os corneal ulcer while wearing the 1-day (b)(6)®® brand contact lens (cls).On (b)(6) 2019 the pt experienced a slight discomfort in the am and in the afternoon the pt removed the suspect os cls.After removal, the pt reported os eye pain.The pt went to an eye care provider (ecp) on (b)(6) 2019 and was diagnosed with an os corneal ulcer and prescribed levofloxacin 1.5 % eye drops qid and odomel eye drops (fluorometholone) 0.1 % qid.The pt had a follow-up appointment on (b)(6) 2019 and was advised the ¿scratch¿ was remaining, no cls wear and return to the ecp on (b)(6) 2019.The family member reported the ¿scratch¿ was on the superior of ¿black eye¿ and the pt was instructed to wait until the ¿white part disappeared until the pt could resume cls wear.The pt was advised to continue using the previously prescribed eye drops remaining.On (b)(6) 2019 the pt returned to the ecp and was advised the event resolved and was allowed to return to cls wear.On (b)(6) 2019 additional medical information was provided by the pts treating ecp as follows: the pt was seen at the clinic on (b)(6) 2019 with complaints of discomfort (persisting from the prior day), foreign body sensation, redness and a ¿white spot¿ in the black eye.No culture was conducted.The va was not affected.Corrected va: 1.2 od/ without aid, os va a little less than 0.06; the pt was prescribed levofloxacin eye drops 1.5% and fluorometholone eye drops 0.1% qid; cls wear was discontinued.Diagnosis: corneal ulcer os; an illustration reflected the corneal ulcer ¿approximately 1 mm in diameter, was located about three-fourth from the center, in the direction to 13 degrees of cornea os; foreign body sensation, redness in conjunctiva was also described in superior the ulcer.¿ on (b)(6) 2019 follow-up appointment: pt had trouble being able to see well with eyeglasses prescribed the day before; changed prescription (not provided); va: 1.2 os; treatment: continue using eye drops previously prescribed.On (b)(6) 2019 follow-up visit: outcome: recovered; discomfort and foreign body sensation resolved; ¿as to the scratch, it epithelized (+) although opacity remains.¿; treatment: discontinued.No return appointment is requested.No additional medical information was received.The lot number of the suspect product is unknown.The os suspect lens was discarded.No evaluation can be conducted.If any further relevant information is received, a supplemental report will be filed.

• Brand Name: 1-DAY ACUVUE TRUEYE (NARA A)
• 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: 9216152
• MDR Text Key: 163162489
• Report Number: 1057985-2019-00105
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: K073485
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/01/2019

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: 1D4
• Device Lot Number: UNK-1D4
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/01/2019
• Initial Date FDA Received: 10/21/2019
• 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
• Patient Age: 14