MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HOUSTON CENTURION SURGICAL PROCEDURE PAK; GENERAL SURGERY TRAY (KIT)

Catalog Number 8065752193

Device Problem Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/12/2020

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 nurse reported that the sleeve was too soft and was getting caught in the incision during a left eye cataract procedure.The sleeve became squeezed and bss would not flow into the anterior chamber when the surgeon would attempt to turn the tip upside down.The procedure was completed without product exchange.There was no patient harm.

Manufacturer Narrative

Additional information provided in h.3, h.6 and h.10.A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.No sample was received for evaluation; therefore, visual and functional testing could not be performed.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.The root cause for this complaint is not known, therefore, specific action with regards to this complaint cannot be taken.All lots are verified that all required inspections 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).

Manufacturer Narrative

Additional information provided in d.10, h.3, h.6 and h.10.A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.The certificate of analysis from the supplier for the sleeves built into this lot confirmed the product was built and released per specifications.Two sleeves were returned and visually inspected.The irrigation holes were aligned 180° opposite to each other.No damage was found on the irrigation center ports.The texture and the ribs on the inner wall of the infusion sleeves were intact.No twist on the shaft was observed during installing the infusion sleeves onto the lab stock tip on the handpiece.There was no difficulty to place the tip onto the sleeves.Saint-gobain certification of analysis was reviewed and confirmed the durometer of the infusion sleeve met specification.There was no perceptible tactile difference when checking for softness, both were similar in hardness.The root cause of the customer's complaint could not be established; the returned samples were evaluated and met specifications.After investigation of this complaint, it has been determined that this sample met specifications; therefore, no corrective action is required at this time.All lots are verified that all required inspections 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).

• Brand Name: CENTURION SURGICAL PROCEDURE PAK
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• MDR Report Key: 9924262
• MDR Text Key: 187372651
• Report Number: 1644019-2020-00186
• 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: 09/22/2020

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 Expiration Date: 07/31/2021
• Device Catalogue Number: 8065752193
• Device Lot Number: 2309471H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2020
• Initial Date Manufacturer Received: 03/13/2020
• Initial Date FDA Received: 04/03/2020
• Supplement Dates Manufacturer Received: 06/16/2020; 09/03/2020
• Supplement Dates FDA Received: 06/29/2020; 09/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CUSTOM-PAK SURGICAL PROCEDURE PACK.