ACUVUE? OASYS? PH

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2020-01-14 for ACUVUE? OASYS? PH manufactured by Johnson & Johnson Vision Care, Inc. ? Usa.

Event Text Entries

[187462308] (b)(4). Initial reporter's phone number: (b)(6).
Patient Sequence No: 1, Text Type: N, H10

[187462309] On 27dec2019 a patient (pt) in mexico reported a diagnosis of bacterial conjunctivitis od while wearing the acuvue? Oasys? Brand contact lenses. The pt reported redness and? Glaze? With a lens on the 2nd or 3rd day of wear. The pt went to an eye care provider (ecp) who prescribed ciprofloxacin eye drops every 4 hours for 7 days, contact lens rest, baby shampoo eye washes tid and warm compresses tid. The pt advised the os was fine, but the ecp advised the pt to treat the os with the prescribed antibiotics prophylactically. The pt returned to contact lens wear on (b)(6) 2019. The pt reported using opti-free solution to clean lenses. On 30dec2019 a call was placed to the pt who provided additional information: the pt reported initial confusion when reporting the date of the event. The pt advised the onset of symptoms began on (b)(6) 2019 and went to the ecp on (b)(6) 2019. The pt provided the medical report from the (b)(6) 2019 visit. Medical report dated 15nov2019: the pt reported to the ecp with od redness, burning sensation,? Mucusy? Discharge, foreign body sensation for 7 days. The pt treated with hot chamomile compresses. Exam od: visual acuity: 20/400; intraocular pressure: 12 mmhg; eyelids: slight secretion; conj: bulbar hyperemia 1+, tarsal papillaes; cornea: clear exam os: visual acuity: 20/40; intraocular pressure: 12 mmhg; eyelids: slight secretion; conj: bulbar hyperemia 1+, tarsal papillaes; cornea: clear impression: ou bacterial blepharoconjunctivitis plan: sophixin (cipro/dexamethasone) 1 drop every 4 hours for 5 days and stop; hyabak 1 drop every 6 hours ou continuous use; do not use contact lens for the 5 days of treatment and use 1 new pair of lenses at the end of treatment; wash lashes with baby shampoo. Multiple calls were placed to the pts treating ecp for additional medical information, but nothing additional was received. The lot number for the os is unknown. The suspect os contact lens was discarded. No additional investigation can be conducted. This report is for the pts os event. The report for the pts od event will be submitted in a separate report. If any further relevant information is received, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1057985-2020-00007
• MDR Report Key: 9588810
• Report Source: CONSUMER,FOREIGN
• Date Received: 2020-01-14
• Date of Report: 2019-12-27
• Date of Event: 2019-11-13
• Date Mfgr Received: 2019-12-27
• Date Added to Maude: 2020-01-14
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: ROSE HARRELL
• Manufacturer Street: 7500 CENTURION PARKWAY
• Manufacturer City: JACKSONVILLE FL 32256
• Manufacturer Country: US
• Manufacturer Postal: 32256
• Manufacturer Phone: 9044433364
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: ACUVUE? OASYS?
• Generic Name: LENSES, SOFT CONTACT, EXTENDED WEAR
• Product Code: LPM
• Date Received: 2020-01-14
• Model Number: NA
• Catalog Number: PH
• Lot Number: UNK-PH
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: JOHNSON & JOHNSON VISION CARE, INC. ? USA
• Manufacturer Address: 7500 CENTURION PARKWAY JACKSONVILLE FL US

Device Sequence Number: 101

• Product Code: ---
• Date Received: 2020-01-14
• Device Sequence No: 101
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention; 2. Deathisabilit	2020-01-14