FDA Adverse Event Malfunction Summary report: N

CATALYS SYSTEM

MDR report key: 7561273 · Received June 1, 2018

Report

Report Number: 3005675890-2018-00033
Event Type: Malfunction
Date Received: June 1, 2018
Date of Event: May 2, 2018
Report Date: June 1, 2018
Manufacturer: JOHNSON & JOHNSON SURGICAL VISION, INC
Product Code: OOE
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT; LASER CORRECTION SYSTEM, MODEL CATALYS-I, THAT HAS A SIMILAR PRODUCT, CATALYS-U WHICH IS DISTRIBUTED IN THE UNITED STATES UNDER 510(K) # K121091. MANUFACTURER DATE UNKNOWN AS IT WAS NOT PROVIDED A REVIEW OF RECORDS RELATED TO THE DEVICE INCLUDING LABELING, COMPLAINT TRENDING, AND RISK DOCUMENTATION WILL BE PERFORMED. UPON COMPLETION OF THIS REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. AMO¿ INVESTIGATION SUBSEQUENTLY IDENTIFIED THAT THE CATALYS SYSTEM MAY HAVE A REMOTE POTENTIAL EVENT WHERE LOSS OF SUCTION DURING LASER FIRING COULD CREATE A HAZARDOUS SITUATION THAT MAY RESULT IN SCORING OF THE POSTERIOR CORNEAL SURFACE. THEREFORE AMO HAS ISSUED AN ADVISORY NOTICE TO REINFORCE INSTRUCTIONS PROVIDED IN PRODUCT TRAINING AND IN THE OPERATOR¿S MANUAL REGARDING SUCTION LOSS DURING A PROCEDURE. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A PROCEDURE AND WHILE LASER WAS FIRING THE SYSTEM EXPERIENCED A SUCTION LOSS. IT WAS REPORTED NO PATIENT INJURY OR SURGICAL INTERVENTION WAS REQUIRED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
402328	CATALYS SYSTEM	CATALYS	OOE	JOHNSON & JOHNSON SURGICAL VISION, INC	CATALYS-I

Patients

Seq	Age	Sex	Outcome	Treatment
1