MAUDE MDR 12249

MDR report key: 12249
Report number: MW1001206
Event key: 0
Event type: 3
Date received: 1994-03-24
Adverse event: 3
Product problem: 3
Patients in event: 0
Reporter occupation: 0
Health professional: 3
Initial report to FDA: 0
Event location: 3

Manufacturer Contact#

Report source: P
Manufacturer link flag: N

Devices#

Seq, Brand, Generic table
Seq	Brand	Generic	Manufacturer	Product code	Model	Catalog	Lot	PMA	510(k)	Implant	Evaluated	Availability
1	FLUOROCON	RIGID GAS PERMEABLE CONTACT LENS	PILKINGTON BARNES-HIND, INC.	HPX	8.15/9.5 DIAM	-600 DIOPTER	HABJR			N		R

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	1994-03-24	0	1. O

Event Narratives#

D

Patient 1

PRODUCT WAS NEVER DISPENSED TO THE PT. VERIFICATION OF BASE CURVE OF LENS RESULTED IN RPTR'S REJECTION OF THE PRODUCT. BASE CURVE IS LABELED 8.15. IT VERIFIES AS 8.20, WELL BEYOND TOLERANCE. CORNEAL HEALTH COULD HAVE BEEN COMPROMISED BY THIS POOR QUALITY CONTROL.

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
B22202	Paraperm O2	Paragon Vision Sciences, Inc.	HPX	2018-02-23
00858174006003	PMMA	LAGADO CORPORATION, THE	HPX	2016-07-29

Type, Submission, Product code table
Type	Submission	Product code	Device	Applicant	Decision date
510(k)	K955777	HPX	PMMA CLASIC	Rand Scientific Corp.	1996-05-16
510(k)	K940106	HPX	KERATOPLASTY SUTURING LENS	Visionary Technologies of Miami, Inc.	1994-05-25
510(k)	K913081	HPX	MULTI-VIEW BIFOCALS	Camp Contact Lenses	1991-10-23
510(k)	K897021	HPX	MARTIN-HENSLEY SEGMENT LENS	Bruce W. Martin O.D. and Edward Hensley	1990-06-22
510(k)	K895411	HPX	OPTIKEM PMMA CONTACT LENS	Optikem Polymers, Inc.	1990-02-27
PMA	P820065S082	HPX	BOSTON LENS II & IV	Polymer Technology Corp.	1994-02-16
PMA	P820063S055	HPX	PARAPERM O2 (PASIFOCON A) RGP CONTACT LENS	CooperVision, Inc.	1994-01-04
PMA	P820063S054	HPX	PARAPERM O2 (PASIFOCON A) RGP CONTACT LENS	CooperVision, Inc.	1994-01-04
PMA	P840004S007	HPX	SATURN II(TM) (SYNERGICON A) CONTACT LENS	Wesley Jessen Corp.	1993-10-14
PMA	P820065S081	HPX	BOSTON LENS II & IV	Polymer Technology Corp.	1993-09-07

MAUDE MDR 12249

Related Records#

Manufacturer Contact#

Devices#

Patients#

Event Narratives#

D

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