FDA Adverse Event Injury Summary report: N

OPTI-FREE REPLENISH

MDR report key: 1961063 · Received January 12, 2011

Report

Report Number: 1610287-2010-00159
Event Type: Injury
Date Received: January 12, 2011
Report Date: December 13, 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: NJ, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

EVALUATION SUMMARY: THE COMPLAINT DEVICE WAS NOT RECEIVED 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 VIA PHONE ON 12/14/2010, 12/20/2010 AND 01/07/2011; VIA MAIL ON 12/13/2010 AND 12/20/2010; AND VIA E-MAIL ON 12/20/2010. (B)(4).

Description of Event or Problem · 1

A CONSUMER REPORTED, HER DAUGHTER EXPERIENCED A SERIOUS VISION PROBLEM AND INFLAMED CORNEAS FOLLOWING THE USE OF THIS PRODUCT. ON (B)(6) 2010, ADDITIONAL INFORMATION WAS RECEIVED FROM THE CONSUMER STATING HER DAUGHTER IS STILL EXPERIENCING DECREASED POOR VISION, BLURRY VISION AND SHE CANNOT DRIVE AT NIGHT. SHE STATED HER DAUGHTER IS WEARING HER GLASSES AND SHE HAS BEEN TO THE DOCTOR TWICE. SHE NOTED, SHE IS UNSURE IF HER DAUGHTER HAS BEEN TREATED WITH MEDICATIONS. ON (B)(6) 2011, ADDITIONAL INFORMATION WAS RECEIVED FROM THE CONSUMER STATING HER DAUGHTER'S VISION IS IMPROVING, BUT IS STILL NOT ONE HUNDRED PERCENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

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	21 YR		Other	ACUVUE SOFT CONTACT LENSES (DATES UNKNOWN)