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

Catalog Number 8065750541

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Capsular Bag Tear (2639)

Event Date 08/18/2020

Event Type  Injury  

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.(b)(4).

Event Description

A customer reported product "poor matching" cassette and other device.During phacoemulsification and intraocular lens implant, the interior chamber suddenly disappeared, resulting in posterior capsule rupture, which led to lens detachment.Intraocular lens implantation was difficult resulting in failure of the operation and visual impairment.Additional information was requested; however, none has been received to date.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Additional information provided in h.3., h.6., and h.10.A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.The customer reported that when phacoemulsification and intraocular lens implantation were performed for the patient, the anterior chamber suddenly disappeared, resulting in posterior capsule rupture, which led to lens detachment into the vitreous cavity.Intraocular lens implantation was difficult, resulting in the failure of the operation and visual impairment of the patient.No sample has been returned for evaluation; therefore, the condition of the product could not be verified.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.In-process controls are established to ensure each final assembled cassette is verified that all required tests have been performed and all acceptance criteria are met prior to release.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.Consumables manufacturing management has been made aware of this complaint through the consumer affairs review meeting.The manufacturer internal reference number is: (b)(4).

• Brand Name: LAUREATE SURGICAL PROCEDURE PAK
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• MDR Report Key: 11163233
• MDR Text Key: 226563044
• Report Number: 1644019-2021-00029
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 8065750541
• Device Lot Number: 2335066H
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 84 YR