FDA Adverse Event Injury Summary report: N

CATALYS SYSTEM

MDR report key: 9517204 · Received December 24, 2019

Report

Report Number: 3005675890-2019-00108
Event Type: Injury
Date Received: December 24, 2019
Date of Event: November 28, 2019
Report Date: November 5, 2020
Manufacturer: JOHNSON & JOHNSON SURGICAL VISION, INC.
Product Code: OOE
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

CORRECTION: H4: MANUFACTURING DATE: THE MANUFACTURING SITE REPORTED THAT THE MANUFACTURING DATE FOR THE DEVICE IS FEBRUARY 1, 2018. H3 OTHER TEXT : PLACEHOLDER.

Additional Manufacturer Narrative · 0

THIS CORRECTION MDR IS BEING SUBMITTED TO ADDRESS INACCURATE INFORMATION IN SECTION F ON THE XML VERSION OF THE PREVIOUS SUBMISSION CAUSED BY A SOFTWARE GLITCH IN THE TRANSMISSION PROCESS. THE INTERNAL NON-CONFORMANCE NUMBERS FOR THIS SOFTWARE ISSUE ARE NR-0148919 AND CAPA-010215.

Additional Manufacturer Narrative · 1

INITIAL REPORTER PHONE NUMBER (B)(6). 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. MANUFACTURING DATE REQUESTED BUT NOT AVAILABLE AT THE TIME OF THIS REPORT. 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. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT A CAPSULE TEAR WAS FOUND DURING THE PHACOEMULSIFICATION TREATMENT AFTER THE CATALYS PROCEDURE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1310078	CATALYS SYSTEM	CATALYS	OOE	JOHNSON & JOHNSON SURGICAL VISION, INC.	CATALYS-I

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other