MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CENTURION SILVER SYSTEM, ACCESSORY, OZIL TORSIONAL HANDPIECE; UNIT, PHACOFRAGMENTATION

Catalog Number 8065750469

Device Problems Material Discolored (1170); Overheating of Device (1437)

Patient Problems Eye Burn (2523); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/06/2023

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 nurse reported that during a cataract surgery an ophthalmic phacoemulsification handpiece was found to be hot, the connector was discolored and the cable was found to be damaged.A patient experienced corneal burn.Additional information has been requested and none received till date.

Manufacturer Narrative

Additional information provided in sections a.1, a.2, a.3, a.4, b.5, b.6, b.7, d.9, h.3, h.6 h.10 the hp was received for testing on this investigation.A visual assessment of the returned sample found connector discoloration, cable damage, a missing red dot, dented irrigation line and strain relief.A flow rate test was performed on the irrigation and aspiration lines of the handpiece which found the handpiece to meet 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.During the burn-in test, the temperature of the hp was measured per the product design specification and was found to be within specifications.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 specifications.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).

Event Description

Additional information received that patient had a iris prolapsed, strong astigmatism, corneal wound leakage for which the patent was sutured and treated with ointment, bandage, therapeutic contact lens, antiobioprophylaxis and diuretic medication.The patent current conditions were not resolved.

• Brand Name: CENTURION SILVER SYSTEM, ACCESSORY, OZIL TORSIONAL 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: 17486516
• MDR Text Key: 320668071
• Report Number: 2028159-2023-01109
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 00380657504695
• UDI-Public: 00380657504695
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K121555
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/14/2023

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065750469
• Device Lot Number: 127RCL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/31/2023
• Initial Date FDA Received: 08/09/2023
• Supplement Dates Manufacturer Received: 08/18/2023
• Supplement Dates FDA Received: 09/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: CENTURION VISION SYSTEM
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 66 KG