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

Catalog Number 8065751155

Device Problem Inability to Irrigate (1337)

Patient Problems Eye Burn (2523); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/27/2022

Event Type  Injury  

Event Description

A physician reported that thermal burn occurred due to irrigation failure during the cataract procedure.It was unknown whether the procedure was completed or not.The soft shell technique was used.Priming passed without problems.During the procedure, it felt that something was stuck, obstruction occurred, irrigation stopped, and noticed that thermal burn occurred.Additional information was received from the customer stating that thermal burn occurred in patient¿s right eye (od) where the intraoperative intraocular pressure (iop) was greater than the perfusion pressure.The outcome of the event was not known with insufficient perfusion due to viscoelastic material, shallow anterior chamber.It was also reported that the burn occurred immediately after us (ultrasonic) tip was inserted into the eye and oscillated.Once the us tip was removed and reinserted, the thermal burn was further intensified by us oscillation.At that time, white liquid was flowing backward from the inside of the eye to the sleeve (from the inside of the eye to the handpiece side).Therefore, the us tip was removed from the eye again, and the us tip and other parts were cleaned.After that, the us tip was reinserted into the eye, and no thermal burn was observed, and the ultrasound emulsification and aspiration were performed as usual.As an action taken an additional suture was done and the procedure type iol insertion was also changed from to iol fixation in sclera.The doctor stated that it only happened in that one case, and the rest of the cases were all fine.The doctor did not know the reason for the thermal burn and wanted to know the possible factors.

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).

Manufacturer Narrative

The lot complaint history and dhr (device history record) were not reviewed as no lot information was available for this complaint.The sample was not received at the investigating site for this complaint report; visual inspection or functional testing could not be conducted.If a sample is returned at a later date, the investigation will be reopened and the sample will be evaluated.The root cause of the customer's complaint could not be established as a sample has not been received.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.After an investigation of this complaint, it has been determined that no action will be taken at this time as a sample was not returned and no root cause could be established.No adverse trends have been observed associated with the reported product and event.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: CONSTELLATION SURGICAL PROCEDURE PACK
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer (Section G): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 15948488
• MDR Text Key: 305140374
• Report Number: 1644019-2022-01031
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 10380657511553
• UDI-Public: 00380657511556
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/15/2023

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065751155
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2022
• Initial Date FDA Received: 12/09/2022
• Supplement Dates Manufacturer Received: 02/15/2023
• Supplement Dates FDA Received: 03/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CONSTELLATION VISION SYSTEM; VISCOELASTIC DEVICE
• Patient Outcome(s): Other