FDA Adverse Event Malfunction Summary report: N

HEALON DUET PRO

MDR report key: 14123818 · Received April 15, 2022

Report

Report Number: 3012236936-2022-01002
Event Type: Malfunction
Date Received: April 15, 2022
Date of Event: March 21, 2022
Report Date: April 15, 2022
Manufacturer: AMO UPPSALA AB
Product Code: LZP
UDI-DI: 05050474651425
PMA / PMN Number: P810031
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

UNKNOWN, INFORMATION NOT PROVIDED. IF IMPLANTED, GIVE DATE: NOT APPLICABLE AS THIS IS NOT AN IMPLANTABLE DEVICE. IF EXPLANTED, GIVE DATE: NOT APPLICABLE AS THIS IS NOT AN IMPLANTABLE DEVICE. PHONE NUMBER: +011(514)7810483. THE HEALON 5 PRO IS NOT RETURNED FOR EVALUATION. THEREFORE; A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE LOT 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. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

Description of Event or Problem · 0

IT IS REPORTED THAT AFTER INJECTION OF THE HEALON5 PRO A SMALL PARTICLE OF PLASTIC WAS OBSERVED IN THE PATIENT'S LEFT EYE. ISSUE WAS NOTIFIED DURING IMPLANTATION OR APPLICATION. IT WAS REMOVED AND THERE WAS NO DELAY IN PROCEDURE REPORTED. NO MEDICAL OR SURGICAL INTERVENTIONS REPORTED. IT WAS NOTED THAT PATIENT'S DAILY ACTIVITIES WERE NOT SIGNIFICANTLY AFFECTED. PATIENT IS FULLY RECOVERED POST-OP. NO OTHER INFORMATION WAS PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1905625	HEALON DUET PRO	AID, SURGICAL, VISCOELASTIC	LZP	AMO UPPSALA AB	10-2400-16	UJ31037	05050474651425

Patients

Seq	Age	Sex	Outcome	Treatment
1		Male