MAUDE Adverse Event Report: ALCON RESEARCH, LLC - ALCON PRECISION DEVICE INTREPID COAXIAL POLYMER CONICAL DISPOSABLE I/A HANDPIECE; DEVICE, IRRIGATION, OCULAR SURGERY

Catalog Number	8065752144
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	06/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample is available that has not yet been received at manufacturing site for evaluation.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 during a surgical procedure the patient experienced posterior capsule rupture which occurred in irrigation/aspiration (i/a) mode.The i/a tip was viewed under the microscope and found to have a burr.The surgery was completed with no additional intervention required.Additional information has been requested.
Additional Manufacturer Narrative
One opened handpiece along with an ia tip in tubing was received in a bag for the reported event.The returned sample was visually inspected.The handpiece was found to be nonconforming with the threads of the i/a tip broken off in the threads of the handpiece.The i/a tip was found to be nonconforming for the threads broken off.There was no burr present on the i/a tip.No lot number was identified with this complaint therefore, a device history record review could not be conducted.A usb was received and reviewed by the manufacturing site.The video shows an i/a tip in use, but the reported issue of a burr is not visible in the video.A burr inside the aspiration port as described in the complaint was not confirmed and a root cause cannot be determined for the complaint as described by the customer.The manufacturer internal reference number is: (b)(4).

• Brand Name: INTREPID COAXIAL POLYMER CONICAL DISPOSABLE I/A HANDPIECE
• Common Device Name: DEVICE, IRRIGATION, OCULAR SURGERY
• 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 ; 8175514979
• MDR Report Key: 12055904
• Report Number: 2523835-2021-00218
• Device Sequence Number: 11765669
• Product Code: KYG
• UDI-Device Identifier: 00380657521449
• UDI-Public: 00380657521449
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• 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): 11/10/2021

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 8065752144
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/06/2021
• Supplement Date Received by Manufacturer: 10/15/2021
• Initial Report FDA Received Date: 06/24/2021
• Supplement Report FDA Received Date: 11/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: CENTURION VISION SYSTEM; CENTURION VISION SYSTEM
• Outcome Attributed to Adverse Event: Other
• Patient Age: 59 YR
• Patient Sex: Female