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

Catalog Number ASKU

Device Problems Complete Blockage (1094); Particulates (1451)

Patient Problems High Blood Pressure/ Hypertension (1908); Anxiety (2328); Capsular Bag Tear (2639); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/12/2022

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 physician reported that during a combined phacoemulsification and vitrectomy surgery for retinal detachment while using an ophthalmic console at the start of the sculpture, in the first groove in the lens, there was sudden hypothalamy (sic) with irreducible anterior incarceration /luxation of the lens.Surgeon suspect that the hypothalamy from an anterior thrust of the vitreous by increase of the patient's blood pressure.Later it was noticed that the irrigation from the console was off.Irrigation was reactivated however the patient has experienced rupture of posterior capsule (pc) and anterior capsule (ac).Followed by all these events patient had also experienced psychological traumatism and anxiety about the subsequent secondary implantation.Additional information has been requested.But none received till date.Additional information received clarified that the ophthalmic phacoemulsification (phaco) tip was also involved in the procedure, the phaco tip was clogged and a milky white solution came out of the tip.

Manufacturer Narrative

A sample was not received at the manufacturing site for evaluation for the report of there was hypothalamy, incarceration of the lens, posterior capsule and anterior capsule tear and the phaco tip was clogged with a white substance coming from the tip; 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: 15578903
• MDR Text Key: 301544279
• Report Number: 2523835-2022-00374
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K161794
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• 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
• Date Manufacturer Received: 12/09/2022
• 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: BSS STERILE IRRIGATING SOLUTION.; CONSTELLATION SURGICAL PROCEDURE PAK.; CONSTELLATION VISION SYSTEM.
• Patient Outcome(s): Other; Required Intervention
• Patient Sex: Female