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	Retinal Detachment (2047)
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 nurse reported a fragmentation needle broke and fell to the back of the patient¿s eye during a procedure and when it was retrieved, it caused a retinal detachment.
Additional Manufacturer Narrative
One opened broken phacoemulsification tip in a specimen container with liquid was received.The phacoemulsification tip was visually inspected and deemed nonconforming.The phacoemulsification tip was broken 1/4" from the distal end with a lightly jagged edge.The phacoemulsification tip had even wall thickness.There was wear on the threads, back of flange and nut corners, that was consistent with use.A review of the device history record traceable to the possible lot numbers, indicates that the product was processed and released according to the product¿s acceptance criteria.Two photos were reviewed.Photos are of two pak labels and a broken phacoemulsification tip with wrench.The reported complaint, product and possible lot information is confirmed.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 inspection does not show any manufacturing issue that would cause the broken phacoemulsification tip.No specific action with regard to this complaint was taken, because the root cause for the complaint issue cannot be determined from this evaluation.All phacoemulsification tips are 100% visually inspected by trained operators using 30x magnification, during the manufacturing process.Any nonconformance, such as the broken phacoemulsification tip 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 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 ; 8175514979
• MDR Report Key: 12321172
• Report Number: 1644019-2021-00534
• Device Sequence Number: 19507132
• Product Code: LRO
• UDI-Device Identifier: 00380657509584
• UDI-Public: 00380657509584
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K880961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2021

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: 8065750958
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/10/2021
• Supplement Date Received by Manufacturer: 11/04/2021
• Initial Report FDA Received Date: 08/13/2021
• Supplement Report FDA Received Date: 12/01/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown