MAUDE Adverse Event Report: ALCON LABORATORIES, INC CATARACT CUSTOM DRAPE PACK; DRAPE, SURGICAL

Lot Number 1503113H

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/04/2013

Event Type  malfunction  

Event Description

Cataract custom pack contained a foreign speck of some material.Discovered during case set-up.New pack obtained.No patient harm.

• Brand Name: CATARACT CUSTOM DRAPE PACK
• Type of Device: DRAPE, SURGICAL
• Manufacturer (Section D): ALCON LABORATORIES, INC; 6201 south freeway; ft worth TX 76134
• MDR Report Key: 3893439
• MDR Text Key: 4652082
• Report Number: 3893439
• Device Sequence Number: 1
• Product Code: HMT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Lot Number: 1503113H
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/18/2014
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 06/25/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR