FDA Adverse Event Other Summary report: N

ACRYSOF

MDR report key: 2060930 · Received March 18, 2011

Report

Report Number: 1119421-2011-00287
Event Type: Other
Date Received: March 18, 2011
Date of Event: February 1, 2011
Report Date: February 17, 2011
Manufacturer: ALCON RESEARCH, LTD. / HUNTINGTON
Product Code: HQL
PMA / PMN Number: P930014
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: VA, US
Reporter Occupation: UNKNOWN

Narratives

Additional Manufacturer Narrative · 1

PRODUCT EVALUATION: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ROOT CAUSE: NO LOT/SERIAL NUMBER OR SAMPLE WAS RETURNED BY THE CUSTOMER. NO ROOT CAUSE CAN BE DETERMINED AT THIS TIME. ACTION TAKEN: NO FURTHER ACTION IS WARRANTED AT THIS TIME. COMPLAINT TRENDS WILL CONTINUE TO BE MONITORED AND FURTHER ACTION WILL BE INITIATED WHEN DEEMED NECESSARY BY THE APPROPRIATE RESPONSIBLE MANAGEMENT PERSONNEL. THE CONSUMER DID NOT PROVIDE ANY CONTACT INFORMATION; THEREFORE, FOLLOW UP WAS NOT ABLE TO BE CONDUCTED. (B)(4).

Description of Event or Problem · 1

A CONSUMER REPORTED THAT FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY, HE HAS TO WEAR RIGID GAS PERMEABLE (RGPS) CONTACT LENSES TO ACHIEVE A VISUAL ACUITY OF 20/20. THE CONSUMER REPORTED HE HAD WORN RGPS FOR YEARS PRIOR TO HIS IOL IMPLANT SURGERIES. THE CONSUMER DID NOT PROVIDE ANY CONTACT INFORMATION; THEREFORE, FOLLOW UP WAS NOT ABLE TO BE CONDUCTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE FIRST EYE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ACRYSOF	INTRAOCULAR LENS	HQL	ALCON RESEARCH, LTD. / HUNTINGTON	SA60AT	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other