FDA Adverse Event Injury Summary report: N

STAR S4 IR ETL EXCIMER LASER

MDR report key: 2870828 · Received December 12, 2012

Report

Report Number: 3006695864-2012-00188
Event Type: Injury
Date Received: December 12, 2012
Date of Event: November 2, 2012
Report Date: November 16, 2012
Manufacturer: ABBOTT MEDICAL OPTICS
Product Code: LZS
PMA / PMN Number: P930016
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: AZ, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

THE CLINIC DID NOT REQUEST SERVICE FOR THE EXCIMER AND DOES NOT SUSPECT THE EXCIMER AS THE CAUSE OF THE DLK. THE CLINIC REQUESTED CLINICAL SUPPORT TO DETERMINE SOURCE OF THE DLK. AMO CLINICAL DEVELOPMENT MANAGERS HAVE BEEN WORKING WITH THIS SITE DUE TO THEIR ONGOING ISSUES WITH DLK. THEY OBSERVED CLEANING AND HANDLING PROCEDURES OF THE CLINIC STAFF. RECOMMENDATIONS WERE MADE TO INSTALL HIGH GRADE HEPA FILTERS IN THE AIR CONDITIONING AND HEATING DUCTS. THE CUSTOMER INDICATED THAT THEY ARE PLANNING ON BRINGING IN AN ENTIRELY NEW AUTOCLAVE TO REPLACE THE TWO THEY HAVE. FOR THE MOST PART, THEY STATE THE DLK IS TRACE. HOWEVER, THEY HAVE HAD INCREASED LEVELS OF DLK SPORADICALLY. INVESTIGATION SO FAR HAS NOT BEEN ABLE TO ESTABLISH A CORRELATION. ALL PERTINENT INFORMATION AVAILABLE TO AMO HAS BEEN SUBMITTED.

Description of Event or Problem · 1

THE CLINIC REPORTED THAT ALL THEIR LASER VISION CORRECTION PATIENTS TREATED ON (B)(6)PRESENTED WITH DLK (DIFUSE LAMELLAR KERATITIS) WITH TWO PATIENTS HAVING 3+ DLK. PATIENTS WERE TREATED WITH TOPICAL STEROIDS AND ALL CASES RESOLVED. THERE WAS NO LOSS OF BCVA WITH ANY OF THE PATIENTS. ADDITIONAL PATIENT INFORMATION WAS REQUESTED HOWEVER THIS WAS NOT PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	STAR S4 IR ETL EXCIMER LASER	EXCIMER LASER	LZS	ABBOTT MEDICAL OPTICS	STAR S4 IR ETL

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention