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

Catalog Number 1MM

Device Problem No Apparent Adverse Event (3189)

Patient Problems Conjunctivitis (1784); Corneal Abrasion (1789); Corneal Ulcer (1796); Dry Eye(s) (1814); Iritis (1940); Keratitis (1944); Pain (1994); Red Eye(s) (2038); Blurred Vision (2137)

Event Date 10/01/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2018, an eye care provider (ecp) called our affiliate in (b)(6) to report a patient (pt) experienced redness and was diagnosed with uveitis in the left eye (os) while wearing the 1-day acuvue moist multifocal brand contact lens.On (b)(6) 2018, additional information was received from the pt: the pt reported the event date of (b)(6) 2018.The pt was initially diagnosed with conjunctivitis in both eyes.The pt reported the os became worse and was diagnosed with uveitis.The pt was prescribed 6 eye drops, antibiotics, sleeping pills, pain relief pills, steroid pills and steroid eye ointment (all unspecified).The pt provided the name of one of the eye drops: vigamox (unspecified dosage, frequency, and duration).The pt reported continued os eye pain.The pt noted that ¿eyesight is worse because of this incident.¿ on (b)(6) 2018, additional information was received from the pt: the pt reported eye pain and a reduction in visual acuity.The pt¿s medical report was requested.On (b)(6) 2018, additional information was received from the pt: the pt reported the treatment is continuing and the eyesight still not recovered.On (b)(6) 2018, additional information was received from the pt: the pt reported that eyesight had recovered a ¿little bit¿.On (b)(6) 2018, the pt¿s medical report was received, and additional information provided: date of visit: (b)(6) 2018.Diagnosis: corneal abrasion, dry eye syndrome, idiopathic keratitis, acute gastritis, central corneal ulcer, regular astigmatism, myopia; ¿treatment: keratitis and corneal abrasion due to cl wear on both eyes; treating for left eye anterior uveitis; requires continuous monitoring and treatment¿.No further information has been received.The suspect os cl was discarded.No product or lot information was available.No analysis could be conducted.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.

Manufacturer Narrative

On 29nov2018, a medical report was received with the following additional information: ¿patient complained about severe eye pain due to toxic conjunctivitis and treated with iv vitamins and pain control pills¿.No additional information has been received.If any further relevant information is received, a supplemental report will be filed.

• Brand Name: 1-DAY ACUVUE MOIST BRAND MULTIFOCAL
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE, INC. ¿ US; 7500 centurion parkway; jacksonville FL
• MDR Report Key: 8028562
• MDR Text Key: 125824121
• Report Number: 1057985-2018-00129
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): Y
• PMA/PMN Number: N18033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 11/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 1MM
• Device Lot Number: UNK-1MM
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/29/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention