MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CENTURION VISION SYSTEM; UNIT, PHACOFRAGMENTATION

Model Number ASKU

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Conjunctivitis (1784); Inflammation (1932); Uveitis (2122); Vitritis (2181); Toxic Anterior Segment Syndrome (TASS) (4469)

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.This is the first of eight reports for this reported patient event.The manufacturer internal reference number is: (b)(4).

Event Description

A surgeon reported that a patient experienced toxic anterior segment syndrome (tass) following a cataract extraction procedure and laser treatment.Upon post-operative examination of the patient, the surgeon noted 3+ aqueous cell, less than 1+ conjunctival inflammation, less than 1+ vitreous inflammation and aqueous fibrin.No cultures were performed and no intervention treatment was provided.The patient's symptoms have resolved without any additional treatment.This report represents the first of three patients for this surgeon.

Manufacturer Narrative

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

Manufacturer Narrative

Additional information provided in sections h.6.And h.10.There were no samples returned for evaluation.There was no further information provided by this customer.With no additional, related information provided, the customers reported event was not able to be confirmed.Based on the information obtained, the root cause of the reported events cannot be determined conclusively.Data will continue to be monitored for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).

• Brand Name: CENTURION VISION SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 12094604
• MDR Text Key: 259223955
• Report Number: 2028159-2021-00698
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• PMA/PMN Number: K121555
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/27/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: ASKU
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/09/2021
• Initial Date FDA Received: 06/30/2021
• Supplement Dates Manufacturer Received: 08/04/2021; 09/03/2021
• Supplement Dates FDA Received: 08/20/2021; 09/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BALANCED SALT SOLUTION.; BESIVANCE.; CENTURION PROCEDURE PAK.; CETAPHIL FACE WASH.; CHANG CANNULA.; CLEARCUT KNIVES.; CUSTOM-PAK PROCEDURE PACK.; CYCLOPENTOLATE.; DUOVISC VISCOELASTIC SYSTEM.; DUREZOL.; INTREPID DISPOSABLE I/A SET.; KETOROLAC.; LIDOCAINE.; MALYUGIN RING.; PCB00 (TECNIS IOL).; PHENYLEPHRINE.; POVIDONE IODINE.; TETRACAINE.; TYLENOL.; VISCOAT VISCOSURGICAL DEVICE.; BALANCED SALT SOLUTION; BESIVANCE; CENTURION PROCEDURE PAK; CETAPHIL FACE WASH; CHANG CANNULA; CLEARCUT KNIVES; CUSTOM-PAK PROCEDURE PACK; CYCLOPENTOLATE; DUOVISC VISCOELASTIC SYSTEM; DUREZOL; INTREPID DISPOSABLE I/A SET; KETOROLAC; LIDOCAINE; MALYUGIN RING; PCB00 (TECNIS IOL); PHENYLEPHRINE; POVIDONE IODINE; TETRACAINE; TYLENOL; VISCOAT VISCOSURGICAL DEVICE
• Patient Outcome(s): Other
• Patient Age: 74 YR