FDA Adverse Event Injury Summary report: N

OPTI-FREE REPLENISH

MDR report key: 1963298 · Received January 14, 2011

Report

Report Number: 1610287-2010-00162
Event Type: Injury
Date Received: January 14, 2011
Date of Event: December 1, 2010
Report Date: December 16, 2010
Manufacturer: ALCON - FORT WORTH/ALCON LABORATORIES, INC.
Product Code: LPN
PMA / PMN Number: K050729
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: PA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

EVALUATION SUMMARY: THE COMPLAINT DEVICE WAS NOT REC'D FOR EVALUATION. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ADDITIONAL INFORMATION WAS REQUESTED BY E-MAIL ON 12/08/2010. A COMPLETED QUESTIONNAIRE AND MEDICAL RECORDS WERE REC'D ON 12/16/2010. (B)(4).

Description of Event or Problem · 1

AN OPTOMETRIST INITIALLY REPORTED A PT EXPERIENCED RED EYES AND DIFFUSE CORNEAL INFILTRATES IN BOTH EYES FOLLOWING THE USE OF THIS PRODUCT. HE STATED THE PT WAS INITIALLY SEEN ON (B)(6) 2010 WITH RED EYES AND CORNEAL INFILTRATES WITH 3+ INJECTION. HE NOTED HE DISCONTINUED CONTACT LENS USE AND PRESCRIBED THE PT AN ANTIBIOTIC 1 DROP EVERY HOUR. AT THIS TIME, THE PT'S BCVA WAS 20/25 IN THE RIGHT EYE AND 20/20 IN THE LEFT EYE. IN F/U, HE REPORTED THE PT WAS SEEN ON (B)(6) 2010 WITH CORNEAL INFILTRATES. HE NOTED AT THIS TIME, THE PT'S BCVA WAS 20/30 IN BOTH EYES. HE REPORTED HE PRESCRIBED THE PT AN ANTIBIOTIC 1 DROP EVERY SIX HOURS. THE OPTOMETRIST REPORTED HE SWITCHED THE PT TO A HYDROGEN PEROXIDE BASED CONTACT LENS SOLUTION AND THE PT IS DOING BETTER.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	OPTI-FREE REPLENISH	LENS CARE DISINFECTING SOLUTIONS	LPN	ALCON - FORT WORTH/ALCON LABORATORIES, INC.	NA	NI

Patients

Seq	Age	Sex	Outcome	Treatment
1	19 YR		Other	ACUVUE 2 SOFT CONTACT LENSES