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

Catalog Number 1DM

Device Problem No Apparent Adverse Event (3189)

Patient Problems Conjunctivitis (1784); Dry Eye(s) (1814); Irritation (1941); Pain (1994); Red Eye(s) (2038); Excessive Tear Production (2235)

Event Date 11/04/2017

Event Type  Injury  

Manufacturer Narrative

Eval: no testing methods performed; no results available since no evaluation performed; unable to confirm complaint; device not returned.

Event Description

On 10nov2017 a johnson and johnson sales representative in (b)(4) reported that an eye care provider (ecp) treated a patient (pt) for ¿severe pain in the right eye upon inserting a 1-day acuvue moist brand contact lens.¿ the pt was diagnosed with corneal erosion and a foreign body inside the eyelid.On 13nov2017 the pt was contacted; additional information was obtained: pt reported experiencing ¿irritation by solution upon inserting the contact lens into the right eye¿ and the irritation was ¿extraordinary.¿ pt reported not being able to open the eye, but managed to remove the suspect contact lens.Pt reported the pain continued after the suspect lens was removed.The pt was seen by an ophthalmologist who diagnosed staining, corneal erosion over the cornea and a foreign body was removed from the eyelid of the od.The treating ecp did not discuss what foreign body was removed from the od.The pt was instructed to d/c contact lens wear, prescribed drops and to rtc (b)(6) 2017.Several attempts were made to obtain additional information from the treating ecp.On (b)(6) 2017 the treating ecp confirmed the diagnosis of corneal epithelium disorder over entire cornea, erosion, conjunctival hyperemia, acute conjunctivitis and foreign body in tarsal of conjunctiva od.The ecp considered the event to be a non-severe because the va was not affected and the pt recovered in a short-time.The pt presented the morning of (b)(6) 2017 with c/o pain, redness, tearing od.The pt reported pain upon inserting a lens then removing the lens and cleaning it with tap water.Rx: removal of foreign body in conjunctiva; ofloxacin eye cream, purified sodium hyaluronate 0.1% and gatifloxacin 0.3% gtts both tid od; d/c contact lens wear.Rtc on (b)(6) 2017.F/u (b)(6) 2017: slight conjunctival hyperemia, corneal epithelium disorder remaining upper nasal side od.No sx¿s were reported by the pt.Rx: continue previously prescribed eye drops.D/c contact lens for 1 week.Rtc on (b)(6) 2017.F/u (b)(6) 2017: recovery, dry eye od.Rx: diquafosol sodium eye drops.Rtc 1 week.No instructions were given to continue to d/c lens wear.On (b)(6) 2017 the treating ecp reported the patient had not returned to the clinic.No additional medical information has been received, no additional medical information is expected.The suspect product 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 2941300104 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) received a medical expense receipt with the additional information: on (b)(6) 2017 the pt was seen at the eye clinic medication: purified sodium hyaluronate 0.1% eye drops 5ml x 1 bottle, gatifloxacin 0.3% 5ml x 1 bottle; treatment: foreign body in conjunctiva removal, tarivid 0.3% eye cream 0.3g.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 MOIST
• 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: 7084128
• MDR Text Key: 93809819
• Report Number: 9617710-2017-05067
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/19/2017

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: 05/01/2022
• Device Catalogue Number: 1DM
• Device Lot Number: 2941300104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2017
• Initial Date FDA Received: 12/05/2017
• Supplement Dates Manufacturer Received: 12/19/2017
• Supplement Dates FDA Received: 01/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2017
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention