MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CENTURION VISION SYSTEM, ACCESSORY, OZIL TORSIONAL HANDPIECE; UNIT, PHACOFRAGMENTATION

Catalog Number 8065751761

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  

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 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.

Event Description

Additional information has been received indicating that the corneal edema had settled down and the patient's vision had improved.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The phacoemulsification (phaco) handpiece was not returned for evaluation.A phaco handpiece non-conformance based review of the batch/lot/serial number was performed and did not reveal any potential contributing factors to the reported complaint.A manufacturing device history record (dhr) review was performed prior to product release to ensure that the product was manufactured in compliance with the device master record.Based on the assessment, the product met release criteria.A review for complaints reported against this lot/batch/serial number was performed.A potentially relevant complaint was found and reviewed as part of this investigation.The product under investigation is not a serviceable device.Therefore, a service record review was not performed.The root cause of the reported event is inconclusive.The manufacturer 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 VISION SYSTEM, ACCESSORY, OZIL TORSIONAL HANDPIECE
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer (Section G): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 15328288
• MDR Text Key: 298985079
• Report Number: 2028159-2022-01281
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 00380657517619
• UDI-Public: 00380657517619
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K121555
• 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: 12/05/2022

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: 8065751761
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/04/2022
• Initial Date FDA Received: 08/31/2022
• Supplement Dates Manufacturer Received: 10/04/2022; 11/07/2022
• Supplement Dates FDA Received: 10/31/2022; 12/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: CENTURION VISION SYSTEM
• Patient Outcome(s): Required Intervention; Other