ARGON-KRYPTON LASER ALCON 8065-6611-01 OPTHALAS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-01 for ARGON-KRYPTON LASER ALCON 8065-6611-01 OPTHALAS manufactured by Alcon Surgical Inc..

Event Text Entries

[1984] A left trabeculoplasty was being performed on patient with argon-krypton laser. Equipment malfunctioned producing 5-6 times amount of energy at standard setting, causing hole in patients retina. Equipment was immediately taken out of service, checked by medical maintenance at famc, and manufacturer notified. Manufacturer checked equipment and found defective micro-chip. Part was replaced and equipment reprogrammed. Equipment back in use and functioning properly. Invalid data - regarding single use labeling of device. Patient medical status prior to event: invalid data. Invalid data - regarding multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. Invalid data - regarding whether event presents imminent hazard. Invalid data - whether device used as labeled/intended. Invalid data - regarding evaluation by user after event. Method of evaluation: invalid data. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: no data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 4438
• MDR Report Key: 4438
• Date Received: 1992-07-01
• Date of Report: 1992-06-24
• Report Date: 1992-06-24
• Date Added to Maude: 1993-05-25
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ARGON-KRYPTON LASER
• Product Code: LLF
• Date Received: 1992-07-01
• Model Number: ALCON 8065-6611-01 OPTHALAS
• Device Availability: *
• Implant Flag: *
• Device Sequence No: 1
• Device Event Key: 4160
• Manufacturer: ALCON SURGICAL INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. No Informationnvalid Deathata	1992-07-01