FDA Adverse Event Injury Summary report: N

ACUVUE OASYS FOR ASTIGMATISM

MDR report key: 2404530 · Received December 6, 2011

Report

Report Number: 1033553-2011-00085
Event Type: Injury
Date Received: December 6, 2011
Date of Event: October 12, 2011
Report Date: December 6, 2011
Manufacturer: VISTAKON
Product Code: HQL
PMA / PMN Number: P040045
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: KY, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

A DEVICE HISTORY REVIEW WAS PERFORMED: 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. NO QUALITY EVENTS ASSOCIATED WITH THIS LOT. THE LOT HISTORY REVIEWED QUARTERLY IN EXECUTIVE MANAGEMENT REVIEW MEETINGS. DEVICE NOT RETURNED. NO EVAL WILL BE PERFORMED. NO CONCLUSION CAN BE DRAWN.

Description of Event or Problem · 1

(B)(4). THE REPORT STATES THE PT HAD WORN ACUVUE 2 BRAND CONTACT LENSES FOR YEARS AND WAS SWITCHED TO ACUVUE OASYS. THE PARENT REPORTS THE PT FIRST EXPERIENCED TEARING THEN BURNING, REDNESS AND PHOTOPHOBIA. THE PARENT REPORTS THE PT WAS DIAGNOSED WITH MULTIPLE CORNEAL ULCERS AND NEOVASCULARIZATION AND REFERRED TO AN OPHTHALMOLOGIST. THE OPHTHALMOLOGIST'S OFFICE STATES THE PT WAS SEEN ON (B)(6) 2011 WITH MULTIPLE SUPERFICIAL, EXTENSIVE STROMAL INFILTRATES WITHOUT STAINING AND WAS DIAGNOSED WITH KERATITIS. THE PT WAS TREATED WITH "AZOSIDE" AND TOBRADEX. AT 2 WEEKS FOLLOW UP, VA WAS 20/20 OD 20/50-1 OS. THIS IS BEING REPORTED DUE TO THE EXTENSIVE TREATMENT AND REPORTED LOSS OF ACUITY. ADD'L INFO HAS BEEN REQUESTED. REMAINING PRODUCT HAS BEEN REQUESTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ACUVUE OASYS FOR ASTIGMATISM	SOFT CONTACT LENS	HQL	VISTAKON	NA	B00BSQ5

Patients

Seq	Age	Sex	Outcome	Treatment
1	16 YR		Other	OPTI FREE REPLENISH LENS CARE SOLUTION