ALCON 1006

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-01-17 for ALCON 1006 manufactured by Alcon Surgical, Inc..

Event Text Entries

[20184] During cataract surgery, physician needed to perform a vitrectomy. The vitrector was opened, connected, but did not cut - another vitrector was opened and used. No injury/harm to patient. Report submitted to fda and usp. 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: 26827
• MDR Report Key: 26827
• Date Received: 1995-01-17
• Date of Report: 1994-07-06
• Report Date: 1994-07-06
• Date Added to Maude: 1995-10-05
• 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: ALCON
• Generic Name: ADVANCED TECHNOLOGY IRRIGATING OCUTOME PROBE
• Product Code: HKP
• Date Received: 1995-01-17
• Catalog Number: 1006
• Device Availability: *
• Implant Flag: *
• Device Sequence No: 1
• Device Event Key: 27609
• Manufacturer: ALCON SURGICAL, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1995-01-17