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

Catalog Number	8065750121
Medical Device Problem Codes	Complete Blockage (1094); Failure to Deliver Energy (1211)
Health Effect - Clinical Code	Corneal Edema (1791)
Date of Event	02/28/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
A government agency reported that an ophthalmic phacoemulsification handpiece was blocked and there was no ultrasound.The patient was experienced with corneal edema and provided with corticosteroids (oral and para ocular injection) and anti inflammatory drugs.One week post operatively the vision was discovered and corneal edema subsided.
Additional Manufacturer Narrative
Additional information was provided in sections h.6 and h.10.The product under investigation is not a serviceable device.Therefore, a service record review was not performed.Specific product identifiers (serial number) were not provided and could not be determined at this time.However, all device history records are reviewed prior to product release to ensure the product was manufactured in compliance with the device master record and meets release criteria.A review for complaints reported against this serial number cannot be performed as the serial number is unknown.Based on the information obtained, the root cause of the reported event is inconclusive.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, ULTRASOUND HANDPIECE
• Common Device Name: 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: 15975766
• Report Number: 2028159-2022-01756
• Device Sequence Number: 6960330
• Product Code: HQC
• UDI-Device Identifier: 00380657501212
• UDI-Public: 00380657501212
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K120912
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: 8065750121
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/23/2022
• Supplement Date Received by Manufacturer: 02/10/2023
• Initial Report FDA Received Date: 12/14/2022
• Supplement Report FDA Received Date: 03/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 65 YR
• Patient Sex: Female