MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. ¿ IRELAND ACUVUE OASYS; LENSES, SOFT CONTACT, EXTENDED WEAR

Catalog Number PH

Device Problem No Apparent Adverse Event (3189)

Patient Problems Corneal Ulcer (1796); Unspecified Infection (1930); Acanthameba Keratitis (1945)

Event Date 04/24/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On 26apr2018, a representative from an eye care provider¿s (ecp) office in (b)(6) called to report that a patient (pt) who wore acuvue oasys contact lenses (cls) was diagnosed with a corneal ulcer in the left eye (os).The representative stated that the pt presented to the ecp on (b)(6) 2018 with ¿losing good eyesight os¿.The pt¿s visual acuity without wearing cls os was tested and ¿it was not very good¿.The pt was instructed to discontinue cl wear for one month and to return to the clinic on (b)(6) 2018.The pt was prescribed fluorometholone eye drops, tobramycin eye drops, cravit (levofloxacin) eye drops, and ecolicin ophthalmic ointment (erythromycin lactobionate) for the os.On (b)(6) 2018, the pt returned to the ecp and there was no change in the condition of the os compared to the first visit.Multiple attempts were made to contact the ecp office for more information, but no further information was provided.Two lenses were received in a lens case.The parameters of the lenses were measured and a visual inspection was performed.One lens was observed to have excess lens material.One lens was observed with no visual attributes noted.The lenses met company standards for base curve, power, center thickness, and diameter.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 l003cmw 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 28may2018 the patient¿s (pt¿s) medical records were received and additional information was provided: on (b)(6) 2018 the pt was seen at the clinic with chief complaint of reduced visual acuity; diagnosis: corneal erosion; infected; culture was conducted; focal area and depth: ¿influence on va is improved; corrected va os: 0.4 (20/50); treatment: antibiotic and anti-inflammatory; pt was instructed to discontinue contact lens (cl) wear.(b)(6) 2018; follow-up (fu) visit: outcome: improvement; va os: 0.2 (20/100); treatment: eye drops application.(b)(6) 2018 fu visit: va os: 0.9 (no conversion).(b)(6) 2018 fu visit: treatment: added diquafosol sodium eye drops.(b)(6) 2018 fu visit: outcome: resolving; va os: 1.0 (20/20); ¿instruction to discontinue cl wear: return to cl wear from next return visit was instructed¿.On 29may2018 a call was placed to the pts treating eye care provider¿s (ecp) and a representative provided additional information: clinic staff confirmed ¿the diagnosis of os, which we had been initially reported as corneal ulcer.The clinic staff reported that corneal ulcer os was noted on the medical record; staining ou was noted as well.The diagnosis was noted as keratitis ou¿.The pt was instructed to return in 1 month; nothing was detected by the culture.On 25jun2018 a call was placed to the pts treating ecp and a representative reported the pt did not return to the clinic after (b)(6) 2018.No additional information was provided.If any further relevant information is received, a supplemental report will be filed.Serious reportable event trends are reviewed quarterly in franchise management review meetings.

• Brand Name: ACUVUE OASYS
• Type of Device: LENSES, SOFT CONTACT, EXTENDED WEAR
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE, INC. ¿ IRELAND; one technological park plassey; limerick ; EI
• MDR Report Key: 7538017
• MDR Text Key: 109048987
• Report Number: 9617710-2018-05035
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): Y
• PMA/PMN Number: P040045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 05/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/01/2022
• Device Catalogue Number: PH
• Device Lot Number: L003CMW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2018
• Date Manufacturer Received: 05/28/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention