MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. ¿ US 1-DAY ACUVUE DEFINE WITH LACREON; LENSES, SOFT CONTACT, DAILY WEAR

Catalog Number 1DL

Device Problem No Apparent Adverse Event (3189)

Patient Problems Corneal Ulcer (1796); Keratitis (1944); Pain (1994)

Event Date 10/14/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On 09jan2018 a patient (pt) in (b)(6) reported eye pain on (b)(6) 2017 when inserting the 1-day acuvue define brand contact lenses.After the suspect contact lenses were removed the pt couldn¿t open the eyes due to the pain.The pt went to an eye care provider (ecp) on (b)(6) 2017 and was diagnosed with deep staining in the left eye.The pt was instructed to discontinue contact lens wear for one week and return for a follow-up appointment.The pt was prescribed tearbalance, niflan and cravit ophthalmic solution.The pt did not return to the clinic as the symptom in the left eye resolved.On 11jan2018 a call was placed to the pts ecp and additional information was provided by a representative: on (b)(6) 2017 the pt was diagnosed with a corneal ulcer and spk in the left eye.Additional medical information was requested.On 11jan2018 a call was received from the pts ecp¿s office and additional medical information was provided: the ¿pts corrected va after cl removal on (b)(6) 2017 on the os 0.5; the corneal ulcer os was located in the center and va decrease was noted¿.The pt presented to the clinic wearing contact lens at noon despite pain in the am.The treating ecp is not the pts prescribing ecp, so the va decrease is unknown if it was the pts normal va.The pt was prescribed tearbalance qid, niflan and cravit ophthalmic solution 1.5% qid os; the ecp requested the pt to return for a recheck in 4 days due to the deep staining, but the pt did not return.The corneal ulcer was not determined to be infectious.The representative reported the ¿staining was deep, scar might be left if it was infected afterwards as it remained untreated.The clinic prescribed the pt niflan and cravit ophthalmic solution 1.5% as prophylaxis against infection¿.The lot number is unknown and the suspect lens was discarded.No additional medical 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 DEFINE WITH LACREON
• 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: 7245949
• MDR Text Key: 99189250
• Report Number: 1057985-2018-00014
• 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,health profe
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/11/2018

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: 1DL
• Device Lot Number: UNK-1DL
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/11/2018
• Initial Date FDA Received: 02/06/2018
• 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