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

Catalog Number	8065751158
Medical Device Problem Code	Suction Failure (4039)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	05/12/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
A physician reported that the phaco tip did not aspirate during pre-phaco; it was like there was a clog in the tip.The wound became white like a burn.After the operation, a white object was observed passing through the aspiration line.The physician suspected that the previous foreign material may have remained in the tip since the tip was reused.The procedure was completed.The patients current outcome is unknown.
Additional Manufacturer Narrative
The previous mdr was submitted under manufacturer report number 1644019-2021-00353.New product information indicated the product was associated with a different manufacturer.Any additional information will be provided under manufacturer report number 2523835-2021-00198.The manufacturer internal reference number is: (b)(4).

• Brand Name: CONSTELLATION SURGICAL PROCEDURE PAK
• Common Device Name: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 19608
• MDR Report Key: 11861759
• Report Number: 1644019-2021-00353
• Device Sequence Number: 3193862
• Product Code: LRO
• UDI-Device Identifier: 00380657511587
• UDI-Public: 00380657511587
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K880961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2021

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
• Operator of Device: Health Professional
• Device Catalogue Number: 8065751158
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/20/2021
• Supplement Date Received by Manufacturer: 05/26/2021
• Initial Report FDA Received Date: 05/21/2021
• Supplement Report FDA Received Date: 06/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1