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 Date 05/05/2021

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 six reports for this reported patient event.The manufacturer internal reference number is: (b)(4).

Event Description

A surgeon reported a patient experienced toxic anterior segment syndrome (tass) following a cataract extraction procedure.The patient presented post-operative day one with more anterior chamber reaction.Upon examination of the patient, the surgeon noted 2+ aqueous cell, less than 1+ conjunctival inflammation and less than 1+ vitreous inflammation.No cultures were performed.The patient's symptoms have resolved without any additional treatment.This report represents the second of three patients for this surgeon.

Manufacturer Narrative

There were no samples returned for evaluation.There was no further information provided by this customer.With no additional, related information provided.The customer 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).

Manufacturer Narrative

Corrected information provided.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: 12087048
• MDR Text Key: 259375572
• Report Number: 2028159-2021-00692
• 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: 09/29/2021

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: 06/07/2021
• Initial Date FDA Received: 06/29/2021
• Supplement Dates Manufacturer Received: 08/04/2021; 09/03/2021
• Supplement Dates FDA Received: 08/20/2021; 09/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BALANCED SALT SOLUTION.; BESIVANCE.; BIOGEL GLOVE.; CENTURION PROCEDURE PAK.; CLEARCUT INTREPID KNIVES.; CUSTOM-PAK PROCEDURE PACK.; DUOVISC VISCOELASTIC SYSTEM.; INTRACAMERAL LIDOCAINE.; INTREPID DISPOSABLE I/A SET.; OCUFLOX.; PCB00 (TECNIS IOL).; PHENYLEPHRINE.; POVIDONE IODINE.; PROTEXIS GLOVE.; TETRACAINE HYDROCHLORIDE.; TROPICAMIDE.; TYLENOL.; ULTRATOUCH GLOVE.; XYLOCAINE.
• Patient Outcome(s): Other
• Patient Age: 72 YR