MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HOUSTON CUSTOM-PAK SURGICAL PROCEDURE PACK; GENERAL SURGERY TRAY (KIT)

Catalog Number ASKU

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Intraocular Pressure Increased (1937); Retinal Injury (2048); Visual Disturbances (2140); Capsular Bag Tear (2639); Zonular Dehiscence (2698)

Event Date 09/19/2019

Event Type  Injury  

Manufacturer Narrative

The customer did not retain the product lot information for this procedure pack, therefore the device history records traceable to the reported procedure pack could not be reviewed.The customer reported a claim against a unidentified surgical product.The documentation attached to this file states the anterior chamber cannulas utilized in cataract surgeries at the reporting facility were supplied by beaver visitec international, inc.Or alcon laboratories, inc.Documentation received noted that during the stromal hydration the anterior cannula came off and flew off the table, at this point was zonular dehiscence with the lens tipping backwards through the dehiscence was noted.A review of the manufacturing records could not be reviewed as the customer did not retain the lot number.No physical sample has been returned for evaluation, therefore, the condition of the product could not be verified.When this type of issue occurs, a sample will need to be returned so that a proper investigation can be conducted.However, the customer provided a photo of possible suspect product; anterior chamber cannula rycroft ref# (b)(4), lot 6038111.The root cause of the customer's complaint could not be established as a sample has not been received and the condition of the product could not be verified.Without analysis of the sample, it is not possible to isolate the root cause.As the root cause is unknown, the relationship, if any, of the device to the reported incident cannot be determined.The root cause for this complaint is not known, therefore, specific action with regards to this complaint cannot be taken.Based on current tracking, there are no adverse trends for this reported complaint.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).

Event Description

A customer reported while performing the cataract procedure patient¿s right eye was injured during the stromal hydration the anterior chamber (ac) cannula came off and flew off the table, at this point was zonular dehiscence with the lens tipping backwards through the dehiscence was noted, further resulting in a large and immediate pressure bolus into the ac which caused a capsular rupture and intraocular lens gets displaced tearing the retina into the vitreous cavity in two places which required an additional emergency procedure performed on the next day, patient ended up with a permanent loss of vision in his right eye; this legal report concerning a claim against the cannula.

Event Description

In review of the provided documentation the actual product allegation could not be determined therefore the suspect was considered as unspecified surgical product, it was also mentioned that per the operative note the product could be an ac [anterior chamber] cannula, however the manufacturer or product details were not available.

• Brand Name: CUSTOM-PAK SURGICAL PROCEDURE PACK
• Type of Device: 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 ; 8007579780
• MDR Report Key: 16478274
• MDR Text Key: 310608184
• Report Number: 1644019-2023-00219
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 76 YR
• Patient Sex: Male