MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HOUSTON SMALL PART KIT; GENERAL SURGERY TRAY (KIT)

Catalog Number 316-3378-522

Device Problem Defective Device (2588)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Manufacturer Narrative

Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).

Event Description

A surgeon reported five sleeves were very flimsy and they experienced trouble entering the eye through a 2.4 millimeter incision and the assistant had to help prevent the sleeve from wrinkling on the way in during sixteen cataract procedures.This is one of two reports for this surgeon.

Manufacturer Narrative

The lot complaint history and device history review (dhr) were not reviewed, as no lot information was available for this complaint.No sample has been returned for evaluation.Therefore, the condition of the product could not be verified.Lot information for the small parts tray containing the sleeves could not be retrieved.The root cause of the customer's complaint could not be established, as a sample has not been received.And the condition of the product could not be verified.Without analysis of the sample, it is not possible to isolate the root cause.As the root cause is unknown.The relationship, if any, of the device to the reported incident cannot be determined.Based on the information in this report, global quality customer affairs is working to address the customer's complaint and will respond separately.The root cause for this complaint is not known.Therefore, specific action with regards to this complaint cannot be taken.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending.And take further action, as appropriate.The manufacturer internal reference number is: (b)(4).

• Brand Name: SMALL PART KIT
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• MDR Report Key: 11358806
• MDR Text Key: 234265312
• Report Number: 1644019-2021-00119
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 316-3378-522
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/15/2021
• Initial Date FDA Received: 02/22/2021
• Supplement Dates Manufacturer Received: 05/17/2021
• Supplement Dates FDA Received: 05/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CUSTOM-PAK SURGICAL PROCEDURE PACK