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

Catalog Number 8065752200

Device Problems Particulates (1451); Suction Failure (4039)

Patient Problems Corneal Edema (1791); Red Eye(s) (2038); Blurred Vision (2137); Visual Disturbances (2140); Eye Pain (4467); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/04/2022

Event Type  Injury  

Event Description

A surgeon reported a patient was scheduled for cataract procedure and had a dense cataract, after hydrodissection and on commencement of lens groove in sculpt setting a milky white liquid described as having the ¿appearance of emulsified lens material¿ was noted in the patient¿s eye.The surgeon was concerned about the material and origin, as he thought he had just commenced aspiration without any phaco at that point of the procedure commenced aspiration without any phaco during procedure.Post-operatively patient developed corneal oedema with vision of hand movements.Both phacoemulsification (phaco) tip, handpiece and fms (fluidics management system) were replaced, and the procedure was carried out without any incident.Additional information received from company representative indicating the patient presented with corneal edema with a visual acuity (va) of hand movements during the post operative examination.Corneal oedema was very slowly improving, but still had significant descemet membrane folds.The patient further presented microcystic epithelial oedema (20 aug 2022) with a sudden increase in pain and redness of eye.Subsequently was put on medications on prednefrin forte q2h (every two hours) and lubricants q2h.It was also stated that preoperatively the patient had 6/19 vision in the eye and the only other thing of note was a small patch of posterior synechiae inferiorly between the iris and anterior lens capsule, otherwise, the eye was healthy.

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

Additional information has been requested.However, none has been received till date.

Manufacturer Narrative

Corrected information provided in section h.6., b.5 and additional information provided in h.10.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The customer did not retain the product lot information for this consumable procedure pack, therefore the device history records (dhr) traceable to the reported procedure pack could not be reviewed.The root cause of the customer's complaint could not be established.A sample was not returned and the video analysis confirmed insufficient information surrounding the occurrence, as well as no evidence was shown to confirm that the vision system contributed to the reported event.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.Based on our current tracking, there are no adverse trends for this reported complaint.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
• 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: 15300807
• MDR Text Key: 298674683
• Report Number: 1644019-2022-00707
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00380657522002
• UDI-Public: 00380657522002
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065752200
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2022
• 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: CENTURION VISION SYSTEM.; OZIL HP.
• Patient Outcome(s): Other; Required Intervention