FDA Adverse Event Injury Summary report: N

OPTI-FREE PLUS

MDR report key: 7111052 · Received December 12, 2017

Report

Report Number: 1610287-2017-00074
Event Type: Injury
Date Received: December 12, 2017
Report Date: March 5, 2018
Manufacturer: ALCON LABORATORIES, INC.
Product Code: LPN
PMA / PMN Number: K981574
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

THE LOT NUMBER WAS NOT PROVIDED AND THE COMPLAINT SAMPLE WAS NOT MADE AVAILABLE FOR EVALUATION. THE MANUFACTURING REVIEW DID NOT INDICATE THAT THIS COMPLAINT WAS DUE TO THE MANUFACTURING PROCESS. NO COMPLAINT OR MANUFACTURING TREND WAS IDENTIFIED. THE ROOT CAUSE COULD NOT BE DETERMINED. (B)(4).

Additional Manufacturer Narrative · 1

THIS PRODUCT IS NOT APPROVED OR INTRODUCED INTO COMMERCIAL DISTRIBUTION IN THE UNITED STATES. HOWEVER, THIS MEDWATCH IS BEING FILED BASED ON A SIMILAR PRODUCT THAT IS SOLD IN THE UNITED STATES UNDER 510(K) # K981574 (OPTI-FREE EXPRESS MULTI-PURPOSE SOLUTION). THE COMPLAINT SAMPLE HAS NOT RETURNED FOR EVALUATION; THE LOT NUMBER IS UNKNOWN. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

Description of Event or Problem · 1

AS INITIALLY REPORTED BY AN EYE CARE PROVIDER (ECP) ON (B)(6) 2017, A PATIENT EXPERIENCED ACANTHAMOEBA KERATITIS AFTER USING THE CONTACT LENS CARE SOLUTION. IT WAS ADDED THAT THE PATIENT'S EYE HAD RECOVERED. NO FURTHER INFORMATION CAN BE OBTAINED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
890361	OPTI-FREE PLUS	ACCESSORIES, SOFT LENS PRODUCTS	LPN	ALCON LABORATORIES, INC.	NA	ASKU

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other