MAUDE Adverse Event Report: ALCON RESEARCH, LLC - ALCON PRECISION DEVICE PHACO TIP; UNIT, PHACOFRAGMENTATION

Catalog Number ASKU

Device Problem Obstruction of Flow (2423)

Patient Problems Eye Burn (2523); Unspecified Eye / Vision Problem (4471); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

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

Additional information provided in h.6.And h.10.A sample was not received at the manufacturing site; therefore, the condition of the product could not be verified.No lot number was identified with this complaint; therefore, a device history record review could not be conducted.A sample was not received at the manufacturing site and no lot information is available, therefore, the root cause for the customer complaint issue cannot be determined.The cause of the reported event cannot be determined with the information obtained, therefore, specific action with regards to this complaint cannot be taken.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No adverse trends have been observed associated with the reported product and event.No additional action is required at this time.The manufacturer internal reference number is: (b)(4).

• Brand Name: PHACO TIP
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LLC - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• Manufacturer (Section G): ALCON RESEARCH, LLC - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 12520044
• MDR Text Key: 272936893
• Report Number: 2523835-2021-00363
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161794
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/30/2021
• Initial Date FDA Received: 09/23/2021
• Supplement Dates Manufacturer Received: 12/10/2021
• Supplement Dates FDA Received: 12/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CENTURION VISION SYSTEM; CENTURION VISION SYSTEM
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 61 YR
• Patient Sex: Male