MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER INTREPID AUTOSERT IOL HANDPIECE, I/A TIP; APPARATUS, CAUTERY, RADIOFREQUENCY, AC-POWERED

Catalog Number 8065751012

Device Problem Device Handling Problem (3265)

Patient Problems Inflammation (1932); Blurred Vision (2137); Vitritis (2181)

Event Date 12/12/2023

Event Type  Injury  

Event Description

A physician reported after implantation of the intraocular lens (iol) implantation procedure, the postoperative visual acuity had decreased after surgery and.There was a fold behind the intraocular lens (posterior capsule), but the vitreous (especially the anterior vitreous) seems to be clouding along it.There also appeared to be a bit of corneal endotheliitis.Surgeon also considered that as another factor other than iol, an ophthalmic reusable irrigation aspiration tip might not have been cleaned and sterilized sufficiently after use.There are four medical device reports associated with this complaint.This report is 3 of 4.

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

Additional information is provided in sections h.6 and h.11.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.The serial is unknown.Therefore, a service history review cannot be performed.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: INTREPID AUTOSERT IOL HANDPIECE, I/A TIP
• Type of Device: APPARATUS, CAUTERY, RADIOFREQUENCY, AC-POWERED
• 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: 18844573
• MDR Text Key: 336960204
• Report Number: 2028159-2024-00377
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 00380657510122
• UDI-Public: 00380657510122
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K112425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/11/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 8065751012
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2024
• Initial Date FDA Received: 03/06/2024
• Supplement Dates Manufacturer Received: 05/15/2024
• Supplement Dates FDA Received: 06/11/2024
• 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
• Treatment: CLAREON IOL WITH THE AUTONOME DELIVERY SYSTEM
• Patient Outcome(s): Other
• Patient Age: 75 YR
• Patient Sex: Male