ACUVUE OASYS BRAND

MDR report key: 3528232 · Received December 13, 2013

Report

Report Number: 1033553-2013-00167
Event Type: Injury
Date Received: December 13, 2013
Date of Event: November 12, 2013
Report Date: December 13, 2013
Product Code: LPL
PMA / PMN Number: P040045
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

DEVICE LABELING SINGLE USE OR REUSE.

Description of Event or Problem · 1

ON (B)(6) 2013 A PATIENT (PT) NOTIFIED (B)(6) REPORTING A CORNEAL ULCER (CU) WHILE WEARING ACUVUE OASYS CONTACT LENSES. AFTER WEARING THE FIRST PAIR OF CL FOR 6 HOURS, THE PATIENT NOTED THE OD WAS "VERY RED" AND THAT THERE WAS A WHITE SPOT IN THE BROWN AREA OF THE OD. THE PATIENT WAS EXAMINED BY AN EYE CARE PROFESSIONAL AND DIAGNOSED WITH A CORNEAL ULCER (CU); THE NATURE OF THE ULCER IS UNKNOWN. THE TREATMENT PLAN INCLUDED VIGAMOX QHR, THEN Q3HRS, THEN QID. BASED ON AGGRESSIVE MEDICAL TREATMENT RECEIVED, THIS EVENT IS REPORTED AS WORST CASE. THE PATIENT HAS RESUMED CL WEAR 5 SEALED BLISTERS AND 1 LENS CASE WERE RETURNED. THE PARAMETERS WERE MEASURED AND A VISUAL INSPECTION WAS PERFORMED. THE LENSES MEET COMPANY STANDARDS FOR BASE CURVE, CENTER THICKNESS AND DIAMETER. NO OTHER VISUAL ATTRIBUTES WERE OBSERVED. THE SOLUTION WAS ALSO TESTED. THE PH AND CONDUCTIVITY WERE IN SPECIFICATION. A DEVICE HISTORY REVIEW WAS PERFORMED. LOT # L0022P8 WAS PRODUCED UNDER NORMAL CONDITION. 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. MDR REPORTABLE EVENT TRENDS ARE REVIEWED IN QUARTERLY MANAGEMENT REVIEW MEETINGS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
652811	ACUVUE OASYS BRAND	SOFT CONTACT LENS	LPL		NA	L0022P8

Patients

Seq	Age	Sex	Outcome	Treatment
1	38 YR		Other\| R	OPTI FREE LENS CARE SOLUTION