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

Catalog Number ASKU

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

Patient Problem Eye Burn (2523)

Event Date 01/05/2022

Event Type  malfunction  

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 the during a phacoemulsification phase of a cataract extraction of the right eye occlusion with white cloudy material noticed in front of phaco tip and small corneal burn was noted.Additional information has been received from the customer stating that the occlusion tone was heard from the ophthalmic console with no system message displayed.There was no wound leakage or sutures required for the burn.There was no patient ill-effect identified.

Manufacturer Narrative

The phacoemulsification handpiece was not returned for evaluation.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.No similar complaints were reported for the product lot/batch/serial under investigation.The product under investigation is not a serviceable device.Therefore, a service record review was not performed.The root cause cannot be determined conclusively.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: INFINITI VISION SYSTEM, ACCESSORY, 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: 13389868
• MDR Text Key: 284674417
• Report Number: 2028159-2022-00098
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K120912
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: BETADINE; BSS STERILE IRRIGATING SOLUTION; BSS STERILE IRRIGATING SOLUTION; BVI CUSTOM EYES KIT; CENTURION VISION SYSTEM, HANDPIECE TIP; CONSTELLATION SURGICAL PROCEDURE PAK; CONSTELLATION VISION SYSTEM; CONSTELLATION VISION SYSTEM; HEALON GV; KELMAN TIP; PHENYLEPHRINE 2.5%; VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE; VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE
• Patient Age: 68 YR
• Patient Sex: Male