FDA Adverse Event Injury Summary report: N

CATALYS SYSTEM

MDR report key: 18759633 · Received February 22, 2024

Report

Report Number: 3012236936-2024-00457
Event Type: Injury
Date Received: February 22, 2024
Date of Event: December 26, 2023
Report Date: February 22, 2024
Manufacturer: AMO MANUFACTURING USA, LLC
Product Code: OOE
PMA / PMN Number: K113479
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: KS, US
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

THE DEVICE WAS NOT RETURNED FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

Description of Event or Problem · 0

IT WAS REPORTED THAT THE DOCTOR HAD A POSTERIOR CAPSULE TEAR IN THE LEFT EYE OF THE PATIENT. DOCTOR DID NOT NOTICE THE TEAR UNTIL SHE WAS REMOVING THE CORTEX AND WAS NOT SURE WHEN TEAR OCCURRED OR WHAT WAS THE CAUSE. CASE WAS REVIEWED WITH THE MD (DOCTOR OF MEDICINE) AND MD STATED THAT PATIENT HAD CONSISTENT FORCE ERRORS DURING INCISION CONFIRMATION BUT DID NOT BREAK SUCTION. MD REFLECTED THAT DOCTOR SHOULD HAVE RESCANNED PRIOR TO ENGAGING THE LASER AND STABILIZED THE PATIENT. SINCE INCIDENT, SURGEON HAS NOT EXPERIENCED ANY ADDITIONAL COMPLICATIONS. NO FURTHER INFORMATION WAS PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
63993	CATALYS SYSTEM	OPHTHALMIC FEMTOSECOND LASER	OOE	AMO MANUFACTURING USA, LLC	CATALYS-U

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown	Other