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

Catalog Number	8065752066
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2022
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 pharmacist reported tip of the pak broke during surgery.There was no shock, due to vibrations during use.There was no patient harm.
Event or Problem Description
D.3.Product manufacturing site updated due to receipt of [product information] g.9.Manufacturer report number corrected and reported under [2523835-2023-00080] d.4.Lot number information updated.
Additional Manufacturer Narrative
D.3.Product manufacturing site updated due to receipt of [product information] g.9.Manufacturer report number corrected and reported under [2523835-2023-00080] d.4.Lot number information updated the manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
One opened phacoemulsification tip broken in a wrench within a bag was received.The phacoemulsification tip was visually inspected and was found to be nonconforming, the phacoemulsification tip was broken at the cone to cannula transition area.The break was very jagged with a thin wall and there were cracks on both pieces at the break area.There was wear on the threads, back of flange and nut corners that were consistent with threading on a 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 reason for breakage is due to an uneven wall thickness creating a weak region at the thinner section.The uneven wall thickness is a manufacturing issue created at the machining process for the phacoemulsification tips.All phacoemulsification tips are 100% visually inspected by trained operators using 30x magnification throughout the manufacturing process.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.The manufacturer internal reference number is:(b)(4).

• Brand Name: CENTURION 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: 16181210
• Report Number: 1644019-2023-00073
• Device Sequence Number: 2633847
• Product Code: HQC
• UDI-Device Identifier: 00380657520664
• UDI-Public: 00380657520664
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K121555
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/19/2023
• 2 Devices were Involved in the Event: 1 2

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: 8065752066
• Device Lot Number: 14PM2D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/22/2022
• Supplement Date Received by Manufacturer: 01/25/2023; 03/23/2023
• Initial Report FDA Received Date: 01/17/2023
• Supplement Report FDA Received Date: 02/20/2023; 04/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2022
• 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 SURGICAL PROCEDURE PACK; CONSTELLATION SURGICAL PROCEDURE PACK; CUSTOM-PAK SURGICAL PROCEDURE PACK; CUSTOM-PAK SURGICAL PROCEDURE PACK; CUSTOM-PAK SURGICAL PROCEDURE PACK
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 57 KG