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 2020-03-03 for ACUVUE? OASYS? PH manufactured by Johnson & Johnson Vision Care, Inc. ? Us.

Event Text Entries

[188140088] (b)(4). (b)(6).
Patient Sequence No: 1, Text Type: N, H10

[188140089] On (b)(6) 2019, a patient (pt) in (b)(6) reported headache, redness, pain, swelling, and pressure while wearing acuvue? Oasys? In the od on (b)(6) 2019. The pt? S od was red upon removal of the suspect cl. The pt did not seek medical attention. The pt reported using saline to clean and rinse cls. The pt reported a daily wear schedule with monthly replacement. No further information was provided. On (b)(6) 2019, a call was received from the pt stating that the od was still swollen, and the pt has not sought any medical attention. The pt reported wearing an old pair of cls previously reported. The pt? S od is currently red and swollen. No further information was provided. On (b)(6) 2020, the pt posted a complaint on an on-line website: the pt reported an allergy to the cls. The pt visited an ophthalmologist who advised the allergy was so severe that the pt is at risk of losing vision. The pt alleges 50% vision of the od. The pt is planning an appointment with a specialist for (b)(6) 2020. The pt noted feeling like? It is getting worse.? On 17feb2020, additional information was received from the pt: the pt did not have the treating eye care provider (ecp) contact information. The pt reported the ecp did not provide a diagnosis but referred the pt to a specialist. No treatment was prescribed. The pt has a specialist visit scheduled for (b)(6) 2020. No further information was provided. This event is being reported as a worst-case event as the diagnosis and treatment were unable to be verified with the treating ecp. 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 b00rhlm was produced under normal conditions. Two opened contact lens cases were received containing three contact lenses for lot # b00rhlm. The parameters of the three open lenses were measured, and a visual inspection was performed. The lenses met company standards for power, base curve, center thickness, and diameter. No visual attributes were observed for open contact lens # 1; open contact lens # 2 revealed an edge tear; open contact lens # 3 revealed a surface tear. 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: 1057985-2020-00021
• MDR Report Key: 9779585
• Report Source: CONSUMER,FOREIGN
• Date Received: 2020-03-03
• Date of Report: 2020-03-02
• Date of Event: 2019-09-30
• Date Mfgr Received: 2020-02-14
• Date Added to Maude: 2020-03-03
• 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: 2020-03-03
• Returned To Mfg: 2020-01-23
• Model Number: NA
• Catalog Number: PH
• Lot Number: B00RHLM
• Operator: LAY USER/PATIENT
• Device Availability: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: JOHNSON & JOHNSON VISION CARE, INC. ? US
• Manufacturer Address: 7500 CENTURION PARKWAY JACKSONVILLE FL US

Device Sequence Number: 101

• Product Code: ---
• Date Received: 2020-03-03
• Device Sequence No: 101
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other; 2. Required No Informationntervention	2020-03-03