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

Catalog Number 8065751526

Device Problems Material Discolored (1170); Material Integrity Problem (2978)

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

Event Date 11/04/2019

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 healthcare professional reported that the sleeve material was softer and a different color; the sleeves did not stand the pressure in the incision.Patient and procedure impact are unknown.The number of patients and devices involved are unknown.

Manufacturer Narrative

Additional information provided in d.10, h.3, h.6 and h.10.The lot complaint history was reviewed; this is the first complaint for the finish goods lot and first for this issue for this lot.The device history record shows the product was released per specifications.Visual inspection of the complaints samples found no obvious defects.The complaint samples were then inspected against the pantone matching system for product color translucent red (pms 500) and met specifications.The supplier hardness test record results were then reviewed and demonstrated the infusion sleeve lot met specifications during evaluation.We then compared the complaint samples with the returned 581249 (good) sleeves by squeezing the infusion sleeves at the hub and tip, there was no perceptible tactile difference when checking for softness, both were similar in hardness.A review of the inspection records for this lot indicated dimensional, visual inspection, product translucent red (pms 500) verification and twist test was performed and all acceptance criteria were met.A complaint sample with bsi was then visually and functionally tested with the console.A lab stock infiniti cassette and tip were used to test with the returned infusion sleeves.The infusion sleeve was able to be attached on the ultrasonic handpiece (hp) without twisting on the tip.With the infusion sleeve mounted onto the hp, the cassette primed and tuned with the hp successfully.Irrigation flow performance with the infusion sleeve was measured and met specifications.No anomalies were observed during visual and functional testing.The root cause of the customer's complaint could not be established as the returned product met specifications.No further action will be pursued at this time as the product met specifications.All lots are verified that all required tests have been performed and all acceptance criteria are met prior to release.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).

Event Description

Additional information was received.The reported deficient was detected during a cataract procedure.The procedure was completed with the same sleeve.

Manufacturer Narrative

Additional information provided in b.5, d.10, and h.3.A product sample was received and it is awaiting evaluation.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: 9410313
• MDR Text Key: 180359910
• Report Number: 1644019-2019-00186
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: 8065751526
• Device Lot Number: 2256078H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2019
• Date Manufacturer Received: 01/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CUSTOM-PAK SURGICAL PROCEDURE PACK.