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

Catalog Number 8065830047

Device Problem Suction Problem (2170)

Patient Problem Retinal Tear (2050)

Event Date 05/28/2020

Event Type  Injury  

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.(b)(4).

Event Description

A customer reported that while the actuation of the cutter probe had been confirmed, the aspiration was poor during surgery.Therefore, had to move close to the retina, causing a hole to be made in the retina.The surgery was completed.The procedure type is unknown.The sales representative, commented that the surgery was completed after laser emitted to the hole within the same procedure.

Manufacturer Narrative

One opened probe was received with tip protector, in a tray along with other items, for the report of aspiration failure.The returned sample was visually inspected and found to be non-conforming with a large amount of orange/brown foreign material on the needle and inside of the port.The sample was then functionally tested for actuation and aspiration and was found to be conforming for both functional tests.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 returned sample was found to be functionally conforming, therefore an aspiration failure as described in the complaint was not confirmed and a root cause cannot be determined for the complaint as described by the customer.No action was taken as the returned probe was functionally conforming.All probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.Any non-conformances found are removed from the lot and scrapped.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No further actions are required.The manufacturer internal reference number is: (b)(4).

• Brand Name: CONSTELLATION SURGICAL PROCEDURE PACK
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• MDR Report Key: 10148199
• MDR Text Key: 194950371
• Report Number: 1644019-2020-00287
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: 8065830047
• Device Lot Number: 2239960H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2020
• Initial Date Manufacturer Received: 05/29/2020
• Initial Date FDA Received: 06/12/2020
• Supplement Dates Manufacturer Received: 08/29/2020
• Supplement Dates FDA Received: 09/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSTELLATION,TABLETOP,JAPAN,; CONSTELLATION,TABLETOP,JAPAN,
• Patient Outcome(s): Required Intervention