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

Catalog Number 1D4

Device Problem No Apparent Adverse Event (3189)

Patient Problems Iritis (1940); Pain (1994); Red Eye(s) (2038)

Event Date 10/08/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2017 a patient¿s (pt) in (b)(6) called to report while the pt was wearing the 1-day acuvue trueye brand contact lens was diagnosed with iritis.No additional information was provided.On (b)(6) 2017 a call was received from the pts parent and additional information was provided: on (b)(6) 2017 the pt reported photophobia, eye pain and redness when inserting the suspect lens in the left eye.On (b)(6) 2017 the pt went to an eye care provider (ecp) and diagnosed with iritis.Pt was prescribed betamethasone sodium phosphate eye drops and gatifloxacin hydrate eye drops qid were prescribed.The pt discontinued contact lens wear until using the eye drops.Return appointment was given for (b)(6) 2017.On (b)(6) 2017, pt returned to clinic and advised the iritis was resolving.Pt was instructed to return to the clinic when completed the previously prescribed eye drops.The pt currently has no pain; photophobia was unknown.On (b)(6) 2017, pt returned to clinic and advised the eye was much better; pt not to return to lens wear and to return to clinic in a week; pt was prescribed gatiflo (gatifloxacin hydrate) eye drops and fluorometholone eye drops were prescribed qid respectively.On (b)(6) 2017 a call was placed to the pts treating ecp and requested a medical interview on (b)(6) 2017.On (b)(6) 2017 the medical interview was conducted and the additional information was provided: on (b)(6) 2017 pt went to the ecp; chief complaint: eye pain and red eye from the previous day diagnosis: iritis os; no findings in the cornea; visual acuity affect: not measured treatment: gatiflo (gatifloxacin hydrate) eye drops qid and betamethasone sodium phosphate eye drops qid; instruction to discontinue the cl wear was not recorded; return to clinic on (b)(6) 2017 was instructed.Follow-up visit on (b)(6) 2017: outcome: resolving; va affect: na, good vision; treatment: gatiflo (gatifloxacin hydrate) eye drops qid and betamethasone sodium phosphate eye drops qid; instruction to discontinue the cl wear was not recorded; return to clinic was instructed upon using up the prescribed eye drops.Follow-up visit on (b)(6) 2017: outcome: resolving; treatment: gatiflo eye drops qid and betamethasone sodium phosphate eye drops qid; instruction to discontinue the cl wear was not recorded; return to clinic a week after was instructed.Follow-up visit on (b)(6) 2017: outcome: resolved.No additional medical information was received.No additional medical information is expected.The suspect lens was discarded.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 4961020106 was produced under normal conditions.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 (b)(6) 2017, our affiliate in (b)(6) contacted the patient¿s (pt) family member for a follow up.The pt¿s family member reported the pt¿s eye ¿got well¿ and the pt returned to contact lens wear per the doctor¿s instruction.On (b)(6) 2017, our affiliate received a copy of the medical report from the pt¿s eye care provider (ecp) and additional information was provided: adverse event: iritis os.Seriousness: non-severe.Causal relationship with the cl: unknown.Course of treatment: on (b)(6) 2017, the patient visited the clinic with a chief complaint of red eye in conjunctiva os, and the above diagnosis was made.Treatment started with eye drops prescription.Findings gradually improved.Cell in anterior chamber: + outcome: recovery.No additional information has been received.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 TRUEYE (NARA A)
• 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: 7034350
• MDR Text Key: 92105847
• Report Number: 9617710-2017-05057
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• 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,Followup
• Report Date: 11/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/01/2022
• Device Catalogue Number: 1D4
• Device Lot Number: 4961020106
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2017
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 20 YR