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

Catalog Number ASKU

Device Problem Particulates (1451)

Patient Problems Foreign Body In Patient (2687); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/07/2021

Event Type  Injury  

Event Description

A customer reported that a non organic white foreign material fell in patient's eye during an intra-ocular lens (iol) implant surgery by using an ophthalmic handpiece.The scheduled procedure was aborted.An unspecified medical/surgical intervention was attempted to remove the foreign material.Additional information has been requested.

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).

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Event Description

Additional information has been received indicating that when the phacoemulsification was started, a white piece (non-organic) shot out of the phaco handpiece.The piece adhered to the iris at 2 o'clock position.

Manufacturer Narrative

An ophthalmic console is a closed system.It is operated with a sterile single use consumable cassette which is designed to isolate the patient fluid path from the console itself.Any surgical instrumentation that would come into contact with the patient would be cleaned and autoclaved by the user prior to surgery, per standard industry practices and company directions for use (dfu).There is no evidence that the design or manufacturing of the infiniti system or phaco handpiece contributed to the reported event.The collected foreign material sample inside a container was received and analysis was performed.Microscopic examination shows a white particle approximately 1.5mm in length.The white particle was isolated and analyzed and found the best match to be melamine formaldehyde (melamine resin).However, the exact identity and origin of the white particle remains inconclusive.It should be noted that handpieces are inspected during manufacturing for particulates.The inspection approach taken follows a statistically valid continuous sampling plan, per military standard 1235c (csp-1).As the cause for the reported events is inconclusive, deviation from the cleaning and sterilization instructions stated in the product directions for use (dfu) may contribute to an outcome, such as reported.The dfu states, "thoroughly clean the handpiece before initial use and immediately after each subsequent use.Do not store or allow the handpiece to dry after use until thoroughly cleaned." specific product identifiers (lot number, batch number, and/or 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 lot/batch/serial number cannot be performed as the lot/batch/serial number is unknown.The lot/batch/serial is unknown; therefore, a service history review cannot be performed.The root cause of the reported event is inconclusive and there is no indication that the phaco handpiece manufacturing process contributed to the reported events.The manufacturer will continue to monitor data for evidence of adverse trending and take further action, as appropriate.

• 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: 13664995
• MDR Text Key: 286556088
• Report Number: 2028159-2022-00284
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K120912
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2022
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female