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

Catalog Number	8065740837
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information provided in d.9., h.3., h.6.And h.11.One opened phacoemulsification tip in a glassine envelope along with a tyvek label was received for the report of phacoemulsification tip was found bent.Sample was visually inspected and found to be conforming for bent condition.Phacoemulsification tip was inspected for nonconformances and bevel orientation was observed to be incorrect and not as per specifications.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 does not confirm the report of the phacoemulsification tip was bent.However, the complaint evaluation confirms that the bevel of phacoemulsification tip was incorrect and not as per specifications.The root cause is a manufacturing related as phacoemulsification tip bevel was oriented incorrectly and missed during inspection.An investigation was completed for the incorrect orientation of phacoemulsification tip bevel.All phacoemulsification tips are hundred percent visually inspected by trained operators using 30x magnification during the manufacturing process.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.The manufacturer internal reference number is: (b)(4).
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 ultrasound tip was found bent before surgery.The procedure type was unknown.The surgery was performed and completed after replacing the tip with another one.No patient impact was reported.

• 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: 20671913
• Report Number: 2523835-2024-02328
• Device Sequence Number: 20884845
• Product Code: HQC
• UDI-Device Identifier: 00380657408375
• UDI-Public: (01)00380657408375(17)281231(11)240129(10)16H9X8
• 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): 02/04/2025

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: 8065740837
• Device Lot Number: 16H9X8
• 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: 10/17/2024
• Supplement Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 11/13/2024
• Supplement Report FDA Received Date: 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2024
• 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: Unknown