MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. ¿ US ACUVUE OASYS1 DAY WITH HYDRALUXE TECHNOLOGY; LENSES, SOFT CONTACT

Catalog Number TSP

Device Problem No Apparent Adverse Event (3189)

Patient Problems Corneal Abrasion (1789); Dry Eye(s) (1814); Edema (1820); Irritation (1941); Pain (1994); Red Eye(s) (2038); Blurred Vision (2137); Burning Sensation (2146); Excessive Tear Production (2235); Discomfort (2330)

Event Date 03/10/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2017 our affiliate in the (b)(6) received an email from an eye care provider (ecp) reporting that a patient (pt) experienced a burning sensation and advised to go to the hospital while wearing an acuvue oasys®1 day brand contact lens.On (b)(6) 2017 a call was placed to the ecps office and a representative reported additional information as follows: the pt felt discomfort in (b)(6) 2017, but reported the pt did not seek medical attention.No additional medical information was provided.On (b)(6) 2017 a call was received from the pts family member who reported that the pt had been experiencing stinging eyes following use of the acuvue lenses and requested a return call.On (b)(6) 2017 a call was placed to the pts family member and additional information was provided as follows: the pt experienced a burning and discomfort in (b)(6) 2017 as the pt was leaving home for dinner.The discomfort continued and worsened, so the pt went to the ecp.The pt reported the ecp advised he/she had a ¿damaged cornea¿.The pt also came to the phone and reported blurry vision due to ¿some excess liquid in the contact lens¿ and kept rubbing the eye due to the discomfort.The pt reported the ecp advised he/she had a ¿bubble¿ in the cornea.On (b)(6) 2017 a johnson and johnson ecp in the (b)(6) placed a call to the pt and additional information was provided: the event date was (b)(6) 2017; the pt reported washing hands and inserting the lenses.The left eye immediately felt uncomfortable and experienced burning and stinging.The pt described the event as when he/she used to clean lenses with h202 and inserted a lens before the solution neutralized.The pt reported the suspect lens was removed immediately and the pt wore glasses for the next thirty minutes before trying to insert another lens in the left eye from the same package.The left eye was still very irritated, but no further stinging on insertion.The pt left home to go to dinner, but reported he/she experienced so much pain the pt had to leave and go to the ecp.The pt reported the optician removed the lenses and checked the vision which was significantly reduced in the left eye and was also advised the cornea had ¿bubbling¿.The pt was advised to go to the hospital for evaluation.The pt reported the eye was examined later that day at the hospital where the left eye was rinsed with saline; pt was prescribed chloramphenicol ointment and no contact lens wear.No follow-up appointment was arranged.The pt reported the hospital used litmus paper to test the ph of the eye and it was reported as ¿acidic¿.The pt wore glasses for two weeks and returned to contact lens wear.The pt reported the remaining lenses in the box were worn without problem; pt reports he/she is happy with the lenses and has good vision and comfort; the pt does report since the (b)(6) 2017 event the eyes seem more dry.The hospital visit record was requested and pt agreed to release the report for review.On (b)(6) 2017 the johnson and johnson ecp who spoke with the pt reports the event reported by the pt is a serious adverse event as the pt did experience the initial decrease in vision; possible corneal erosion.No additional medical information has been received.The lot # is unknown and the suspect product was discarded.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 26oct2017, our affiliate in (b)(6) received additional medical information from the patient¿s (pt) eye care provider (ecp): visit date: (b)(6) 2017.L: sph -5.75; va: l: 6/6; wear history: current; len worn: soft daily; avg no day: 7; avg hrs/day: 15-18.Rfv: since putting in the l lens this morning ¿ put the cls in and then saw in the case there were bits of scale in the solution.Since then the eye is stingy red.Aftercare current lens: comfort: os: poor, very irritated, red and uncomfortable.Put cls in and then saw in the case that there were bits of scale in the solution ¿ since then the eye is stingy, red, and blurry ¿ getting worse as the eye is very irritated.Vision: os: poor 6/18 c specs rx.Signs/sx: os: redness ¿ yes in le, irritation/dryness ¿ yes in le and watery, no itchiness/discharge, or photophobia, no other.Os: given aqua drops to put in le until pt gets to hes to provide some temporary relief ¿ pt took hycosan but advised not to use if stinging.No sleep/swim/shower/water.Anterior segment grading; blepharitis: os: normal; meibomian gland dysfunction: os: normal; conjunctival redness: os: 2-mild; limbal redness: os: 2-mild; papillary conjunctivitis: os: normal; conjunctival staining: os: normal; upper lid: os: h0p0; left corneal grading: deep staining + edema, no visible infiltrates, anterior chamber clear.Observations: (b)(6) 2017 ¿ advised to go to hes today ¿ given letter and explained need to go asap as va reduced.Advised to cease lens wear + return once given all clear for health check.F/u visit: (b)(6) 2017; aftercare current lens; comfort: os: good; vision: os: spx 6/6-1; signs/sx: os: not red/irritated; current lens: os: none today, recovering from cls injury.Anterior segment grading; blepharitis: os: normal; meibomian gland dysfunction: os: 1-trace; conjunctival redness: os: 1-trace; limbal redness: os: normal; papillary conjunctivitis: os: normal; conjunctival staining: os: normal; upper lid: os: 0p0f; left corneal grading: no stain, cornea clear, anterior chamber clear.Observations: (b)(6) 2017 ¿ eyes ¿ slightly dry ¿ mgd inferior and superior be ¿ advised eye bag to help.On (b)(6) 2017, our affiliate in (b)(6) received additional medical information from the pt¿s from the treating hospital: visit date: (b)(6) 2017.Dx: left corneal abrasion ¿ superficial.Investigations: slit lamp examination ¿ no infiltrate.Va: lva: 2/60 ph 6/18+2.Treatment: prescribing eye drops g levofloxacin 6 x a day le.Tear film supplements ¿ advice given to continue with current.Verbal advice given ¿ no cl x 2/52, if worse to reattend.Outcome: discharge to gp.Primary dx: le superficial (illegible).Medicine: illegible.Ophthalmic referral information for gp.Cornea: edema.Left: sph -5.75, va 6/18.Additional information: pt attended today for a health check c/o reduced vision, red, watery eye since putting in a new cl this morning (oasys 1 day) he/she noticed stinging straight away and then pieces of ¿lime scale¿ in the contact lens case.Vision is reduced 6/18, there is edema and staining on the central cornea le.Pt has not swam, showered, slept in cls.Symptoms are getting worse and advise emergency referral to another for suspected corneal edema and staining (grade 4).History: referred by optician.L) red, painful noted @ 10:00 am today.Cl wearer.Noted corneal central staining.Solution? residue from the cl container.Examination: left: lva: unaided 2/60; ph: 6/18+2; irrigated with nacl; no infiltrate; cl (illegible); paranasal; anterior chamber: clear and quiet.Daily scl wearer: last worn yesterday; wears cl 10-12hr x 7/7; occ sleeps with cl; no shower with cl; diagnosis: le superficial corneal abrasion; treatment: levofloxacin 6x a day, no cl wear, if worse to reattend.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.(b)(4).

• Brand Name: ACUVUE OASYS1 DAY WITH HYDRALUXE TECHNOLOGY
• Type of Device: LENSES, SOFT CONTACT
• 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: 6963411
• MDR Text Key: 89811085
• Report Number: 1057985-2017-00119
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K042275
• 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: 10/26/2017

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 Catalogue Number: TSP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/25/2017
• Initial Date FDA Received: 10/19/2017
• Supplement Dates Manufacturer Received: 10/26/2017
• Supplement Dates FDA Received: 11/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention