MAUDE Adverse Event Report: ALCON LABORATORIES, INC. ALCON; UNIT, PHACOFRAGMENTATION

Model Number 8065752201

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/09/2019

Event Type  malfunction  

Event Description

Integrity of sterile product within a surgical supply pack.Mayo cover for the centurion machine was packaged in a defective manner; having a slash cut through it.Discovered prior to use & prior to break in aseptic technique.Obtained another single use mayo cover.No patient harm or compromise in sterile surgical field.

• Brand Name: ALCON
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON LABORATORIES, INC.; 6201 south freeway; fort worth TX 76134
• MDR Report Key: 9334797
• MDR Text Key: 166771041
• Report Number: 9334797
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8065752201
• Device Catalogue Number: 8065752201
• Device Lot Number: 2275618H
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/21/2019
• Event Location: Hospital
• Date Report to Manufacturer: 11/18/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 30295 DA
• Patient Weight: 102