MAUDE Adverse Event Report: ALCON RESEARCH, LTD.; VITRECTOMY PACK

Device Problems Device Damaged Prior to Use (2284); Incorrect Device Or Component Shipped (2962); Manufacturing, Packaging or Shipping Problem (2975); Scratched Material (3020)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/08/2016

Event Type  malfunction  

Event Description

The operating room staff opened a vitrectomy pack to find a "yellow cafeteria style" tray that is not typically included in the pack.The tray was plastic with several scuffs, scratches, and markings on it.Despite finding the tray, this pack was used for the procedure.There was no apparent affect on the patient.The packaging was not saved so no identifiers are available for this report.

• Type of Device: VITRECTOMY PACK
• Manufacturer (Section D): ALCON RESEARCH, LTD.; 20511 lake forest dr.; lake forest CA 92630
• MDR Report Key: 6105494
• MDR Text Key: 59985667
• Report Number: 6105494
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Other Device ID Number: 23 GAUGE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2016
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/24/2016
• Event Location: Hospital
• Date Report to Manufacturer: 10/24/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO
• Patient Age: 74 YR
• Patient Weight: 73