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

Catalog Number 8065752914

Device Problem Inability to Irrigate (1337)

Patient Problems Burn(s) (1757); Corneal Edema (1791); Corneal Clouding/Hazing (1878)

Event Date 08/04/2023

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 customer reported that the patient experienced corneal burn of the incision at 2.2mm, the incision was in the axis of the irrigation.The ophthalmic operating console had abnormal irrigation with abnormal noise after the removal of sleeve from the eye.The sleeve was changed still the abnormal irrigation was observed.The patient had follow-up on same day had two corneal sutures, a bandage contact lens changed on day three visit.The patient was scheduled with further follow-ups on day seven and day fourteen.The patient¿s post-operative treatment included tobrex eye drops, dexafree and azyter indocollyre.

Manufacturer Narrative

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

Event Description

A customer reported that the patient experienced corneal burn of the incision at 2.2mm, the incision was in the axis of the irrigation.The ophthalmic operating console had abnormal irrigation with abnormal noise after the removal of sleeve from the eye.The sleeve was changed still the abnormal irrigation was observed.The patient had follow-up on same day had two corneal sutures, a bandage contact lens changed on day three visit.The patient was scheduled with further follow-ups on day seven and day fourteen.The patient¿s post-operative treatment included tobrex eye drops, dexafree and azyter indocollyre.Additional information received via follow response the physician reported that during the cataract surgery that an ophthalmic handpiece exhibited occlusion and the patient experienced wound leakage and corneal opacity due to corneal burn and collapsing of the anterior chamber.A seidel was observed for two weeks despite suture and contact lens.It resolved spontaneously at day-15.There were two (2) corneal descemet folds remain, as well as a slight corectopia (due to the iris being drawn towards the incision), without any vitreous wick.The postoperative hypotony with secondary incarceration of the iris towards the endothelium of the incision.The event of corneal opacity was persisted one month postoperatively.The patient was treated with topical anti-inflammatories, topical antibiotics, sutures and contact lens plaster.The patient was scheduled with sutures ablation after six months.

Manufacturer Narrative

The product under investigation is not a serviceable device.Therefore, a service record review was not performed.A handpiece (hp) was returned for testing on this investigation.A non-conformance-based review of the 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 serial number was performed.No similar complaints were reported for the product serial under investigation.The hp was received for testing on this investigation.A visual assessment of the returned sample found no visual nonconformities.The handpiece was connected to a calibrated resistance breakout box, where the input and output impedance were found to be within specification.A flow rate test was performed on the irrigation and aspiration lines of the handpiece which found the handpiece to meet specifications per product specifications.The returned sample was connected to a calibrated system.The handpiece tuned successfully and completed a five-minute burn-in test with the system set at 100% ultrasonic and torsional power.The handpiece was connected to dynamic tuning fixture (dtf) for stroke length testing on the longitudinal and torsional movements which found the handpiece to meet alcon specifications.Corneal burn is an issue that is occasionally reported with cataract surgery.According to the pennsylvania patient safety advisory abstract: preventing corneal burns during phacoemulsification, march 2010, vol.7, no.1: 23-25, most corneal burns can be traced to issues related to surgical technique and not to malfunctioning equipment.The handpiece was found to meet specifications; 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: CENTURION VISION SYSTEM, ACCESSORY, ACTIVE SENTRY 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: 17556605
• MDR Text Key: 321246507
• Report Number: 2028159-2023-01132
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 00380657529148
• UDI-Public: 00380657529148
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K161794
• 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: 11/23/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 8065752914
• Device Lot Number: 14133U
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/04/2023
• Initial Date FDA Received: 08/16/2023
• Supplement Dates Manufacturer Received: 10/09/2023; 10/27/2023
• Supplement Dates FDA Received: 11/03/2023; 11/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: AZYTER INDOCOLLYREX 4.; BSS STERILE IRRIGATING SOLUTION.; CENTURION VISION SYSTEM (ACTIVE SENTRY).; CUSTOM-PAK SURGICAL PROCEDURE PACK.; DEXAFREE X8.; DUOVISC VISCOELASTIC SYSTEM.; IMPLANT CT ASPHINA 209MP +25D.; INJECTOR BLUEMIXS.; TOBREX EYEDROPS.
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 66 KG