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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Corneal Ulcer (1796); Pain (1994); Red Eye(s) (2038)

Event Date 09/28/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2018 a representative from an eye care provider¿s (ecp) office in (b)(6) called to report a patient (pt) had redness and pain os on insertion of a 1-day acuvue® trueye® brand contact lens on (b)(6) 2018.The symptoms persisted on removal of the suspect lens.The pt presented to the ecp¿s office on (b)(6) 2018 and was diagnosed with a corneal ulcer and erosion os.The pt was instructed to discontinue contact lens wear until the symptoms resolve and pt is to return to clinic.Pt was prescribed ofloxacin gel forming "ophtheamic" solution, odomel ophthalmic suspension and erycoli ophthalmic ointment.The pt returned to the ecp office for follow-up on (b)(6) 2018 and (b)(6) 2018.No further instructions for follow-up were given to the pt.The representative reported redness and os pain are persisting.No additional medical information was provided.On 22oct2018 a call was placed to the pts treating ecp and additional medical information was requested.No additional medical information was provided.On 29oct2018 a call was placed to the pts treating ecp and additional medical information was requested, but nothing additional was received.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 5257140108 was produced under normal conditions.The suspect lens was discarded.If any further relevant information is received, a supplemental report will be filed.Serious reportable event trends are reviewed quarterly in franchise management review meetings.

Manufacturer Narrative

On 12nov2018, additional information was received in a written report from the treating eye care professional (ecp): the patient (pt) presented to the clinic complaining of pain and redness in the left eye (os).¿diagnosis: corneal ulcer os; ¿infectiveness: admitted¿; culture performed (unspecified results); ¿focal site: off pupil, superior part of os at 12 o¿clock position; treatment: ofloxacin gel forming ophthalmic solution, tobracin ophthalmic solution and ecolicin ophthalmic ointment¿; pt was instructed to discontinue contact lens (cl) wear.The pt returned to the clinic on (b)(6) 2018; ¿outcome: back on the recovery track was noted¿; pt was instructed to discontinue cl wear.The pt returned to the clinic on (b)(6) 018; ¿va: os 1.2; pt was instructed to discontinue cl wear; pt was instructed to return to the clinic but did not return.¿seriousness: not serious; causal relationship with cl: cannot be denied as the event occurred while the pt was wearing cl; outcome: improved.¿ on 21nov2018, additional information was received the treating ecp clinic: a representative reported that the pt has not returned to the clinic since (b)(6) 2018.No additional information has been received.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. ¿ IRELAND; one technological park plassey; limerick ; EI
• MDR Report Key: 8056725
• MDR Text Key: 126907735
• Report Number: 9617710-2018-05066
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): Y
• PMA/PMN Number: K073485
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 11/12/2018

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 Expiration Date: 04/01/2023
• Device Catalogue Number: 1D4
• Device Lot Number: 5257140108
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/19/2018
• Initial Date FDA Received: 11/09/2018
• Supplement Dates Manufacturer Received: 11/12/2018
• Supplement Dates FDA Received: 12/06/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 44 YR