MAUDE MDR 9370968

MDR report key: 9370968
Report number: 1057985-2019-00135
Event key: 0
Event type: 3
Date received: 2019-11-25
Adverse event: 3
Product problem: 3
Patients in event: 0
Reporter occupation: 1
Health professional: 3
Initial report to FDA: 3
Event location: 3

Manufacturer Contact#

Contact: ROSE HARRELL
Address: 7500 CENTURION PARKWAY JACKSONVILLE FL 32256 US
Phone: 904-904-9044
Report source: M
Manufacturer link flag: Y

Devices#

Seq, Brand, Generic table
Seq	Brand	Generic	Manufacturer	Product code	Model	Catalog	Lot	PMA	510(k)	Implant	Evaluated	Availability
1	ACUVUE? 2?	LENSES, SOFT CONTACT, EXTENDED WEAR	JOHNSON & JOHNSON VISION CARE, INC. ? US	LPM	NA	AV2	B00RKPH					N

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2019-11-25	0	1. O; 2. R

Event Narratives#

No narrative records found.

Type, Submission, Product code table
Type	Submission	Product code	Device	Applicant	Decision date
PMA	P010019S087	LPM	FOCUS NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES	Alcon Laboratories, Inc.	2026-05-29
PMA	P080011S201	LPM	Biofinity Sphere; Biofinity XR Sphere; Biofinity Energys; Biofinity Toric; Biofinity XR Toric; Biofinity Multifocal	CooperVision, Inc.	2026-05-04
PMA	P040045S144	LPM	VISTAKON® (senofilcon A) contact lenses	Vistakon, Division of Johnson & Johnson Vision Car	2026-05-04
PMA	P040045S143	LPM	VISTAKON® (senofilcon A) Contact Lenses	Vistakon, Division of Johnson & Johnson Vision Car	2026-04-29
PMA	P040045S142	LPM	VISTAKON® (senofilcon A) Brand Contact Lenses	Vistakon, Division of Johnson & Johnson Vision Car	2026-04-17