MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - HOUSTON CUSTOM-PAK SURGICAL PROCEDURE PACK; GENERAL SURGERY TRAY (KIT)

Catalog Number 9255-28

Device Problem Insufficient Information (3190)

Patient Problems Corneal Edema (1791); Toxicity (2333)

Event Date 02/03/2016

Event Type  Injury  

Manufacturer Narrative

The pack and products lots specific to this event are not known; therefore, lot history and device history record review is not possible.There were no samples returned for evaluation.Prior to release of all custom pak surgical procedure pak lots, sterilization cycle parameters are verified for acceptability.The root cause of the customer's complaint is not known; a sample was not returned for investigation.(b)(4).

Event Description

A scrub technician reported that a patient was observed with toxic anterior segment syndrome (tass) and corneal edema one day following a cataract extraction procedure.The customer could not identify specific product contributor to the event.The tass was reported and resolved during the patient's two week postoperative visit.No additional information is expected.

• Brand Name: CUSTOM-PAK SURGICAL PROCEDURE PACK
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LTD. - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer (Section G): ALCON RESEARCH, LTD. - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer Contact: eddie darton, md, jd ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175686660
• MDR Report Key: 5542628
• MDR Text Key: 41717930
• Report Number: 1644019-2016-00608
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 9255-28
• Device Lot Number: ASKU
• Other Device ID Number: 00380651831353
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR