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

Model Number	V3.0
Medical Device Problem Codes	Decrease in Suction (1146); Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported that during a cataract surgery an ophthalmic operating console did not aspirate the cataract and no ultrasounds were heard.There was no report of any patient harm.Additional information has been requested.Additional information has been received indicating that the procedure was completed successfully as the console could aspirate.There was no patient harm.
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).
Additional Manufacturer Narrative
Additional information is provided in sections d.9,h.3,h.6 and h.10.Code 1211 has been removed.The company service representative examined the system and was unable to confirm or replicate the reported event.The system was then tested and met all product specifications.A system non-conformance based review of the batch/lot/serial number was performed and did not reveal any potential contributing factors to the reported complaint.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.A potentially relevant complaint was foundand reviewed as part of this investigation.The complaint was regarding system message (sm) [tune failed ¿ handpiece voltage low (short circuit)], and the root cause was inconclusive.The system was found to meet specifications in relation to the reported event; therefore, 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
• 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: 15065188
• Report Number: 2028159-2022-00964
• Device Sequence Number: 5426168
• Product Code: HQC
• UDI-Device Identifier: 00380657521609
• UDI-Public: 00380657521609
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K120912
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: V3.0
• Device Catalogue Number: 8065752160
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/24/2022
• Supplement Date Received by Manufacturer: 09/20/2022
• Initial Report FDA Received Date: 07/20/2022
• Supplement Report FDA Received Date: 10/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown