MAUDE Adverse Event Report: ACUVUE OASYS BRAND CONTACT LENSES; SOFT CONTACT LENS

Lot Number L0026KZ

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Bacterial Infection (1735); Corneal Scar (1793); Corneal Ulcer (1796); Dry Eye(s) (1814); Pain (1994); Red Eye(s) (2038); Excessive Tear Production (2235)

Event Date 04/01/2014

Event Type  Injury  

Event Description

On (b)(4) 2014, a pt contacted our firm to report she received a new order of acuvue oasys contact lenses (cl) and inserted the 1st pair on (b)(6) 2014.The pt said she noticed a film on both lenses shortly after inserting them.She said her vision was cloudy.The pt said she removed the pair at the end of the day and inserted a new pair the following day and those lenses also developed a film on them a short while after insertion.The pt said she wore that pair on lenses for 2 or 3 days, taking them off and cleaning them with opti-free replenish contact lens solution during the day and at the end of the day.The pt said she inserted a 3rd pair on (b)(6) 2014 and a film developed on those lenses causing cloudy vision and the pt developed pain in her left eye (os) which she described as feeling like glass in her eye.The pt said she removed the lenses and her os was red.She said she wore glasses for 2 days before seeing her eye care professional (ecp) on (b)(6) 2014; at that time her os was very red, painful and sensitive to light.The pt said she was told she had a corneal ulcer os and was treated with antibiotics, saw her ecp frequently, the corneal ulcer has resolved and there is a scar under her os lower eye lid.The pt said her vision was not affected.We received a copy of the pt's treatment record on (b)(6) 2014.The record indicates the pt was initially seen (b)(6) 2014.Chief complaint, the pt's left eye (os) hurts, is red, waters, burning, headaches, and photophobia.The record indicates the signs and symptoms were only in the pt's os.The symptoms were worsening and the duration was constant.The pt reported that the onset was tuesday, (b)(6)."the symptoms are present and worsen when wearing contact lenses." the pt tried artificial tears but they did not help.Note in record: "sat.Pt put in a set of new contacts, but they got really foggy, so she removed them and put in a new pair.By tuesday, (b)(6) she put in a new pair of contacts and her left eye was bothering all day.She is not sure what happened.Once she removed the contacts, all the symptoms came and nothing has made it feel better." the pt had no pertinent ocular history or pertinent past medical history.The pt had been taking zyrtec.Spectacle rx: os dva 20/25-.External exam: ocular adnexa and nodes normal.Eyelids and lashes clean, healthy and free of defects.Slit lamp exam (sle): tears demonstrate normal surface qualities.Corneal epithelium, stroma and endothelium clear and healthy.Bulbar and palpebral conjunctiva are healthy and white.Chambers are deep and free of cells and flare.Iris appears healthy, normal anatomy and convexity.Impressions: bilateral dry eye syndrome.Left eye: peripheral corneal ulcer; bacterial corneal ulcer/ therapeutic rx: vigamox 0.5% 1 drop os q2h while awake x 7 days.Tx cornea: left eye: rx lubricating ointment as directed.Rx artificial tears prn, monitor condition at suggested intervals.The pt was instructed to return to clinic (rtc) on or about (b)(6) 2014.The pt rtc on (b)(6) 2014.The record notes the following: examination: dry eye/blepharitis/ocular allergy.Chief complaint: eye strain/ fatigue, eyes sensitive to light, eye get watery really fast.Os: reports red eye.Va spectacle rx: os 20/25-.Sle: tears demonstrate normal surface qualities.Corneal epithelium, stroma and endothelium clean and healthy.Bulbar and palpebral conjunctiva are healthy and white.Chambers are deep and free of cells and flare.Iris appears healthy, normal anatomy and convexity.Impressions: bilateral dry eye syndrome; dry eye syndrome (contact lens related).Left eye: bilateral corneal ulcer.Condition has improved.Treatment: bilateral: artificial tears.Rx: lubricating ointment.Rtc for medical eval.Monitor condition at suggested intervals.Orders: rtc on or about (b)(6) 2014.The pt rtc on (b)(6) 2014: chief complaint: pt reports red eye and light sensitivity.The symptoms are improving.Sle: tears demonstrate normal surface qualities.Corneal epithelium, stroma and endothelium clear and healthy.Bulbar and palpebral conjunctiva are healthy and white.Chambers are deep and free of cells and flare.Iris appears healthy, normal anatomy and convexity.Va os: 20/25-.Impressions: bilateral dry eye syndrome; dry eye syndrome (contact lens related); left eye: bacterial corneal ulcer; condition has improved; condition is stable.Treatment cornea: left eye: rx artificial tears prn; rx lubricating ointment as directed; discontinue cl wear until instructed otherwise.Discontinue treatment.Monitor condition at suggested intervals.Instruct pt to immediately report any change in condition outside of expected and discussed symptoms.Treatment dry eye: bilateral artificial tears; rx lubricating ointment; rx lubricating gel; monitor condition at suggested intervals; continue current treatment.Called ecp's office and was told the (b)(6) 2014 visit was the last visit in their office.One sealed lister, one lens case containing one lens and one open blister containing 2 lenses were received.The parameters of the lenses were measured and a visual inspection was performed.The lenses met company standards for base curve, center thickness, and diameter.No visual attributes were observed.There was not enough solution to measure ph and conductivity.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 l0026kz was produced under normal conditions.If add'l medical or product info is received, we will report it within 30 days of receipt.Mdr reportable event trends are reviewed quarterly in franchise management review meetings.

Manufacturer Narrative

Device labeling single use or reuse.

• Brand Name: ACUVUE OASYS BRAND CONTACT LENSES
• Type of Device: SOFT CONTACT LENS
• Manufacturer Contact: rose harrell ; p.o. box 10157; jacksonville, FL 32216 ; 9044433647
• MDR Report Key: 3848537
• MDR Text Key: 18797992
• Report Number: 1033553-2014-00043
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040045
• 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
• Report Date: 05/22/2014

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: 09/01/2018
• Device Lot Number: L0026KZ
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/12/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/24/2014
• Initial Date FDA Received: 05/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2013
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: OPTI FREE REPLENISH LENS CARE SOLUTION
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 31 YR