MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HOUSTON CONSTELLATION FRAGMENTATION PAK; GENERAL SURGERY TRAY (KIT)

Catalog Number	8065750958
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/16/2024
Type of Reportable Event	Malfunction
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 the fragmentation tip got broken and fell into the retina during surgery.Surgeon managed and removed broken tip from retina.It was unknown if the surgery was completed.There was no information about procedure type and patient harm.
Additional Manufacturer Narrative
Additional information provided in d.9., h.3., h.6.And h.11.One opened broken phacoemulsification tip without a wrench was received.Sample was visually inspected and found to be nonconforming.The tip of the was observed to be broken off.The tip was not returned.Breakage was slightly jagged with dark in color marks at break area.Wall thickness was observed to be even.Wear observed on threads, back of flange, and nut corners consistent with threading on handpiece.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.The complaint evaluation confirms the phacoemulsification tip was broken.The root cause for the broken phacoemulsification tip cannot be determined from this evaluation.The phacoemulsification tip visual inspections do not show any manufacturing issues that would cause the broken phacoemulsification tip.The exact root cause for the broken phacoemulsification tip is unknown; therefore specific action with regards to this complaint cannot be taken.All phacoemulsification tips are hundred percent visually inspected by trained operators using thirty times magnification during the manufacturing process.Any nonconformance, such as the broken phacoemulsification tip exhibited on the returned opened sample, are 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 FRAGMENTATION PAK
• Common Device Name: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer (Section G): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 20459749
• Report Number: 1644019-2024-02401
• Device Sequence Number: 18345749
• Product Code: LRO
• UDI-Device Identifier: 00380657509584
• UDI-Public: (01)00380657509584(17)270131(11)240205(10)16HJV2
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K880961
• 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): 03/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 8065750958
• Device Lot Number: 16HJV2
• 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: 09/18/2024
• Supplement Date Received by Manufacturer: 02/17/2025
• Initial Report FDA Received Date: 10/16/2024
• Supplement Report FDA Received Date: 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2024
• 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
• Patient Sex: Female