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

Catalog Number 8065750469

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Macular Edema (1822); Inflammation (1932); Loss of Vision (2139); Eye Pain (4467); Toxic Anterior Segment Syndrome (TASS) (4469)

Event Date 05/10/2022

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 after cataract surgery on the left eye, the patient felt pain, vision reduced (vision loss) and there was a reaction in the anterior chamber cell (++) and tyndall (+).There was a mild conjunctival inflammation and diagnosed with toxic anterior segment syndrome.The patient was examined and result shows aqueous cell 2+ and increase in macular edema and the patient received an intravitreal injection with triesence.The patient was prescribed with post operative steroids, antibiotics and non-steroidal anti-inflammatory drugs.Additional information received clarifying the reporter suspects phacoemulsification handpiece for the events.

Manufacturer Narrative

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

Event Description

Additional corrected information received indicating that the suspect product is ophthalmic handpiece and not the ophthalmic visco surgical device.

Manufacturer Narrative

Specific product identifiers (serial numbers) 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.No further information was able to be obtained from this customer.With no additional, related information provided, the customers reported event was not able to be confirmed.Based on the information obtained, the root cause of the reported event 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: 14976890
• MDR Text Key: 295613225
• Report Number: 2028159-2022-00917
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K120912
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065750469
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: ACUNEX VARIO; CENTURION VISION SYSTEM; DICLOABAK 3X/DAY; DUOVISC OPHTHALMIC VISCOSURGICAL DEVICE; POVIDONE IODINE 10%; TETRACAÏNE UD; TOBRADEX 1X/DAY, 5X/DAY (POST-OP); TOBRAMYCINE
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female