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

Model Number ASKU

Device Problem Use of Incorrect Control/Treatment Settings (1126)

Patient Problems Eye Burn (2523); Unspecified Eye / Vision Problem (4471); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/10/2021

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 physician reported a relapsing problem with the system user settings and a patient experienced a phacoemulsification (phaco) burn during a cataract procedure.Additional information was received from the physician.The physician reported the phaco tip occluded during sculpt mode and system occlusion tone was heard at the beginning of a right eye cataract surgery.The patient developed a corneal phaco burn resulting in corneal opacity, shallowing of the anterior chamber, with gaping and leakage.The physician indicated he sutured the eye, applied an ocular sealant and a contact lens.The physician indicated the patient developed an induced post-operative astigmatism and one week later the eye was resutured.No additional information is expected.This is one of two reports.

Manufacturer Narrative

No photos or videos are available to review.No service has been requested by the customer; therefore a service record review cannot be performed.The serial number (s/n) was not provided and could not be determined based on the information provided.Therefore, manufacturing information could not be obtained.The root cause cannot be determined conclusively.Manufacturer will continue to monitor data for evidence of adverse trending and take further action, as appropriate.

• Brand Name: CENTURION VISION SYSTEM
• 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: 12519877
• MDR Text Key: 272931669
• Report Number: 2028159-2021-01091
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121555
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ASKU
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: PHACO TIP; PHACO TIP
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 61 YR
• Patient Sex: Male