MAUDE Adverse Event Report: JOHNSON AND JOHNSON VISION CARE INC. ACUVUE ADVANCE PLUS BRAND CONTACT LENS; SOFT CONTACT LENS

Lot Number B00BF96

Device Problems Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)

Patient Problems Corneal Abrasion (1789); Corneal Ulcer (1796); Foreign Body Sensation in Eye (1869); Unspecified Infection (1930); Irritation (1941); Pain (1994); Red Eye(s) (2038); Swelling (2091); Blurred Vision (2137); Corneal Infiltrates (2231)

Event Date 11/01/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, a pt (pt) called to report that he/she received multiple lenses in a single blister package of the acuvue advance plus contact lens (cl).The pt advised that he/she did use the lenses and they "irritated his/her eye".The pt advised that he/she went to the emergency room ((b)(6) 2014) and was told that he/she had a corneal abrasion.The pt also advised that he/she was "on his/her third appointment because of this." on (b)(6) 2014 a call was placed to the pt's treating eye care professional (ecp).A rep at the ecp's office advised that the pt was diagnosed with a corneal ulcer os.The rep advised that the pt stated that he/she experienced a foreign body sensation in the os.The pt went to the emergency room and was prescribed erythromycin ointment.The pt visited the ecp the following day, (b)(6) 2014 and was instructed to begin vigamox eye drops q3 hours and use the erythromycin ointment only at bedtime.On (b)(6) 2014 the pt returned to the ecp for a follow-up visit and was instructed to continue vigamox eye drops q 4 hours and also to continue the erythromycin ointment at bedtime.

Manufacturer Narrative

The exam revealed that the pt had 2 corneal infiltrates that were "lighter".On (b)(6) 2014, the erythromycin ointment was discontinued.On (b)(6) 2014, the pt returned to the ecp for a follow-up appointment and the exam revealed that the ulcer was healed, but tiny infiltrates were healing slowly.The vigamox eye drops were changed to qid and the pt was instructed to return for follow-up exam on (b)(6) 2014.The ecp's rep returned the call with additional info.The pt was seen on (b)(6) 2014 for a follow-up visit.The rep advised that the os corneal ulcer and the infiltrates were healed.The medication was discontinued and the pt was allowed to resume cl wear.The rep advised that the os corneal ulcer was located inferior and the ecp did consider the ulcer to be infectious.The pt is to follow-up with his prescribing ecp.The product has been requested for return for eval, but it has not yet been received.A lot history review was performed and revealed the batch did not show any abnormalities in monomer and solution testing.All parameters tested were within specifications.All sterilization requirements were successfully completed.If additional info is received, will report within 30 days of receipt.Serious reportable event trends are reviewed quarterly in executive mgmt review meetings.

Manufacturer Narrative

One lens case, one open blister with no lens, and three sealed blisters were returned.The parameters of two lenses were measured and a visual inspection was performed.The lenses meet company standards for base curve, center thickness, and diameter.No visual attributes were observed.The solution was also tested; the ph was in specification; there was not enough solution to measure conductivity.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.Actual device evaluated, no failure detected, unable to confirm complaint, visual inspection.The patient identifier is: (b)(4).

Manufacturer Narrative

On 2015-06-01 the patient¿s medical records were received regarding the (b)(6) 2014 corneal ulcer os event.The additional information is as follows: on (b)(6) 2014 the pt presented to the emergency department: presentation: presenting complaint: patient states when he/she took his contacts out this evening he/she developed a sensation that something was in the eye.Eye is red, lid swollen.States vision is not affected.Mechanism of injury: unknown.Pain: complains of pain in the left eye, pain currently 6 out of 10 on a pain scale.Pain began 1 hour ago.Eent: eyes are tearing on left eye lid(s) swollen; denies blurred vision; visual acuity: 21:31 left eye va: 20/30, pupil size 3mm, react to light; administered medications: proparacaine drops 0.5% 4 drops os; the pt was diagnosed with corneal abrasion os and given an rx for erythromycin 5mg/g ophthalmic ointment, apply 1 ribbon every 8 hours.The pt was discharged from the er with instructions to f/u with ecp the following day.On (b)(6) 2014 the pt presented to his/her ecp; chief complaint: os took cl out last night and had immediate fb sensation, va slightly blurred; diagnosed with corneal abrasion in er last pm.Pt used e-mycin since last evening with no change.Eye and eyelid red and puffy today.No previous history.Base eye exam: os: 20/25 - glasses; slit lamp and fundus exam: os: 1+ erythema/edema; 2+ injection; haze, inf infiltrate under epi defect; cornea: drawing depicts 2 infiltrates @ 6 o¿clock; anterior chamber: deep and quiet; iris: round and reactive.A/p: 1.Corneal ulcer os ¿ continue e-mycin q hs; begin vigamox q 2-3 hours os; recheck tomorrow am; cannot rule out (b)(6) although appears unlikely.Medications: moxifloxacin (vigamox) 0.5% eye drops , place 1 drop into the os every 2 hours ¿ start (b)(6) 2015.F/u and disposition: return in 1 day for corneal ulcer recheck.(b)(6) 2014 f/u appointment with ecp: reason for visit: corneal ulcer os recheck; dx: corneal ulcer, os.Base eye exam: os va: 20/25.Slit lamp and fundus exam: os: external: normal; lids/lashes: normal; conjunctiva: 1 + injected 360; cornea: 2 subepithelial round infiltrates; anterior chamber: deep and quiet; iris: round and reactive; lens: clear; vitreous: normal.Progress notes: recheck corneal ulcer os ¿ eye is feeling better this morning.Was given vigamox to use q 2-3 hours.Assessment and plan: corneal ulcer left healing, with two infiltrates, less than 1 mm; continue ciloxan q 3 hours, ilotycin hs; recheck 1-2 days.(b)(6) 2014 f/u appointment with ecp: reason for visit: recheck corneal ulcer os.Base eye exam: os: va: 20/20 ¿ glasses.Slit lamp and fundus exam: os: external: normal; lids/lashes: normal; conjunctiva/sclera: white and quiet, red cleared now; cornea: two inferior spots subepithelial with some edema surrounding.No stain; anterior chamber: deep and quiet; iris: round and reactive; lens: clear; vitreous: normal.Progress notes: recheck ulcer os ¿ eye feeling better.Still very dry.Using vigamox every 2-3 hours and ointment at night.Assessment and plan: corneal ulcer healed, two light infiltrate remain.Continue drops every 4 waking hours; ilotycin q hs.Recheck 5-7 days.(b)(6) 2014 f/u appointment with ecp: reason for visit: recheck corneal ulcer os.Base eye exam os va: 20/20-2 ¿ glasses.Slit lamp and fundus exam: os: external: normal; lids/lashes: normal; conjunctiva/sclera: white and quiet; cornea: two tiny infiltrates, one breaking up eithelium intact; anterior chamber: deep and quiet; iris: round and reactive; lens: clear; vitreous: normal progress notes: recheck peripheral corneal ulcer os.Pt is now noticing glare/halos since last week.Os vision is more fuzzy.General comments: pt is using vigamox drops every 4 hours left eye.Pt stopped using ilotycin ung (b)(6) 2014 after calling to confirm assessment and plan: ulcer healed.Tiny infiltrates clearing slowly.Vision symptoms from inferior spots and glasses instead of cl use.Continue drops qid then recheck in one week.(b)(6) 2014 f/u appointment with ecp: reason for visit: recheck corneal ulcer os.Base eye exam os va: 20/20 ¿ glasses.Slit lamp and fundus exam: os: external: normal; lids/lashes: normal; conjunctiva/sclera: white and quiet; cornea: two light scar spots inferiorly.No stain or edema; anterior chamber: deep and quiet; iris: round and reactive; lens: clear; vitreous: normal progress notes: in today for recheck of corneal ulcer os, compliant with drops and it is feeling better.Corneal ulcer healed.Infiltrates cleared with scarring lightly.Resume contacts, stop drops.F/u: return if symptoms worsen or fail to improve.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.(b)(6).

• Brand Name: ACUVUE ADVANCE PLUS BRAND CONTACT LENS
• Type of Device: SOFT CONTACT LENS
• Manufacturer (Section D): JOHNSON AND JOHNSON VISION CARE INC.; jacksonville FL
• Manufacturer Contact: rose harrell ; po box 10157; jacksonville, FL 32247 ; 9044433647
• MDR Report Key: 4316999
• MDR Text Key: 5243875
• Report Number: 1033553-2014-00113
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032340
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup,Followup
• Report Date: 06/01/2015

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: 03/01/2017
• Device Lot Number: B00BF96
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2015
• Initial Date Manufacturer Received: 06/01/2015
• Initial Date FDA Received: 12/04/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/04/2015; 06/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR