MAUDE Adverse Event Report: ALCON RESEARCH, LLC - ALCON PRECISION DEVICE CONSTELLATION VISION SYSTEM, HANDPIECE TIP; UNIT, PHACOFRAGMENTATION

Catalog Number	8065740837
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Eye Burn (2523)
Date of Event	04/18/2024
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
A physician reported that patient experienced cream dust was generated in a case where nuclear hardness was not that high and burns also appeared on the wound during cataract with (iol implant) surgery.The surgery was completed.There was no patient harm.
Additional Manufacturer Narrative
One opened phacoemulsification tip in a wrench, in a bag was received for the report of cream dust was generated and burns also appeared on the wound.Sample was visually inspected and found to be conforming, functional occlusion test was performed and found to be nonconforming.Phacoemulsification tip inner diameter was pinned and piece of yellowish foreign material was extracted.Occlusion flow check was again performed and found to be conforming.The foreign material was sent for particle analysis.Particle analysis found the foreign material to best match viscoat.A review of the device history record traceable to the reported lot number, indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.Particle analysis found the foreign material to best match viscoat.Viscoat is not a material that is used in the phaco tip manufacturing process or in the packaging process of the phacoemulsification tip.How and when viscoat was in the eye after phaco tip used cannot be determined from this evaluation and a root cause cannot be determined for the complaint as described by the customer.The most likely root cause for the viscoat is surgical material.A possible contributing factor to the thermal injury is if the viscoat occluded or partially occluded the phacoemulsification tip during use it would cause the phacoemulsification tip heat up and could potentially cause a thermal burn.The exact root cause for the foreign material is unknown, therefore specific action with regards to this complaint cannot be taken.All phacoemulsification tips are 100% visually inspected by trained operators using 30x magnification during the manufacturing process.Any nonconformance, such as the phaco tip cannula bent exhibited on the returned opened sample, is removed from the lot, and scrapped.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No adverse trends have been observed associated with the reported product and event.No further actions are required.The manufacturer internal reference number is: (b)(4).

• Brand Name: CONSTELLATION VISION SYSTEM, HANDPIECE TIP
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LLC - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• Manufacturer (Section G): ALCON RESEARCH, LLC - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 19307975
• Report Number: 2523835-2024-00963
• Device Sequence Number: 12595898
• Product Code: HQC
• UDI-Device Identifier: 00380657408375
• UDI-Public: (01)00380657408375(17)280630(11)230706(10)15W3TU(21)NA
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K101285
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 8065740837
• Device Lot Number: 15W3TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2024
• Supplement Date Received by Manufacturer: 09/06/2024
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 10/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CONSTELLATION VISION SYSTEM
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown