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 Conjunctivitis (1784); Dry Eye(s) (1814); Iritis (1940); Keratitis (1944); Neovascularization (1978)

Event Type  Injury  

Manufacturer Narrative

(b)(4). Initial reporter phone number: (b)(6).

Event Description

On 07nov2019 an email was from a patient (pt) who reports being treated by an eye care provider (ecp) for staining (affected eye not provided) while wearing the 1-day acuvue® trueye® brand contact lens. On 11nov2019 additional medical information was provided by the pt: the pt went to the ecp and diagnosed with staining on os. The pt was advised to discontinue contact lens wear for 7 days and prescribed gatifloxacin ophthalmic solution 0. 3%, hyalein ophthalmic solution 0. 1% and tarivid eye ointment 0. 3%. The pt visited the ecp 3 times in (b)(6) 2019. On 19nov2019 additional medical information was received from the pts treating ecp: diagnosis: corneal erosion, acute conjunctivitis and keratitis superficialis diffuse os; slight iritis os was also noted os. Focal site: ¿severe staining os was in the superior part of the cornea, which might be on pupil. Staining was also noted in the inferior part. Fine keratitis diffused in periphery¿; infectiveness: unconfirmed; va: not affected; va was not measured; ecp visit dates: (b)(6) 2019; treatment: gatifloxacin ophthalmic solution 0. 3% tid, hyalein ophthalmic solution tid, tarivid eye ointment hs were prescribed on (b)(6) 2019, event recovered and all medications were discontinued on (b)(6) 2019. The ecp recommended the pt to apply softear opthalmic solution for dry eye. The pt was not instructed to discontinue cl wear or to return to the clinic for follow-up. The last date was ecp visit was (b)(6) 2019. The ecp instructed pt to wear lenses ¿within 12 hours and rest the eye once a week. ¿ ¿contact lens over-wear might be the cause of neovascularization os. ¿ no additional medical information was received. The date of event is reported as (b)(6) 2019. The lot number of the suspect is unknown. The suspect os contact lens was discarded. No evaluation can be completed. 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: 9446151
• MDR Text Key: 185043407
• Report Number: 1057985-2019-00141
• 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: consumer,foreign,health profe

Reporter Occupation

• Type of Report: Initial
• Report Date: 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 1D4
• Device Lot Number: UNK-1D4
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Patient Treatment Data

Date Received: 12/10/2019 Patient Sequence Number: 1