MAUDE Adverse Event Report: ALCON RESEARCH, LLC - ALCON PRECISION DEVICE ALCON MICROSURGICAL INSTRUMENTS, CANNULA OPHTHALMIC; CANNULA, OPHTHALMIC

Catalog Number	8065149530
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Corneal Clouding/Hazing (1878); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/06/2023
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 healthcare professional reported that during a vitrectomy surgery the tip came off the metal shaft and dislodged intra-ocularly.The surgeon was able to retrieve it with forceps and it came out and surgery was completed.There was no patient harm.Additional information received indicated that after removal of the tip from left eye as here was retinal contusion superior to the macular hole from the impact of the silicone tip dislodging into the eye during injection and patient experienced retinal hemorrhage and lens opacification which required surgical intervention.
Additional Manufacturer Narrative
A sample was not received at the manufacturing site for evaluation for the report of tip came off and dislodged intra-ocularly, retinal hemorrhage, lens opacification, intervention; therefore, the condition of the product could not be verified.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 photo given by the customer was reviewed by the manufacturing site.Photo shows a soft tip cannula blister with the product and lot information is confirmed.The reported issue could not be confirmed from the photo.A sample was not received at the manufacturing site and the product was processed and released according to the product¿s acceptable criteria, therefore, the root cause for customer complaint issue cannot be determined.The exact root cause for this complaint is unknown, therefore, specific action with regards to this complaint cannot be taken.All assemblies are 100% inspected for the soft tip during the manufacturing process to ensure that the product meets release acceptance criteria.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 additional action is required at this time.The manufacturer internal reference number is: (b)(4).

• Brand Name: ALCON MICROSURGICAL INSTRUMENTS, CANNULA OPHTHALMIC
• Common Device Name: CANNULA, OPHTHALMIC
• 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: 17878111
• Report Number: 2523835-2023-00508
• Device Sequence Number: 7417969
• Product Code: HMX
• UDI-Device Identifier: 00380651495302
• UDI-Public: 00380651495302
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 8065149530
• Device Lot Number: 15TPCK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/08/2023
• Supplement Date Received by Manufacturer: 12/16/2023
• Initial Report FDA Received Date: 10/05/2023
• Supplement Report FDA Received Date: 01/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2023
• 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: Required Intervention; Other
• Patient Age: 65 YR
• Patient Sex: Unknown