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

Catalog Number ASKU

Device Problem Partial Blockage (1065)

Patient Problems Capsular Bag Tear (2639); Intraocular Pressure Decreased (4468); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/29/2022

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 customer reported that during cataract surgery an ophthalmic surgical console output was slow during a surgery (actually for about 18 mo according to the surgeon).It took too long to cut through the lens and resulted in a tear in the eye.The surgeon planned to used a different lens.New information received indicating machine was unable to break up even small fragments and switched to the coaxial i&a instead.The chamber fluctuated more than normal during this step and it was noted that the irrigation outside the eye on continuous mode was somewhat weaker than normal (lower flow).Posterior capsular tear requiring anterior vitrectomy procedure.Patient¿s issues was resolved.

Manufacturer Narrative

A sample was not received at the manufacturing site for evaluation for the report of phaco problems as well as energy high at times; 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: 16059113
• MDR Text Key: 306240796
• Report Number: 2523835-2022-00490
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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
• Initial Date Manufacturer Received: 11/30/2022
• Initial Date FDA Received: 12/28/2022
• Supplement Dates Manufacturer Received: 03/15/2023
• Supplement Dates FDA Received: 04/11/2023
• 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: 3-PIECE IOL; CENTURION VISION SYSTEM; DUOVISC; DUOVISC VISCOELASTIC SYSTEM; OZIL TORSIONAL HANDPIECE; SINSKY HOOK
• Patient Outcome(s): Other; Required Intervention