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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CENTURION VISION SYSTEM; UNIT, PHACOFRAGMENTATION
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ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CENTURION VISION SYSTEM; UNIT, PHACOFRAGMENTATION Back to Search Results
Catalog Number 8065751763
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
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.The manufacturer internal reference number is: (b)(4).
 
Event Description
A pharmacist reported six patients experiencing endophthalmitis.This is one of three reports from this facility.
 
Manufacturer Narrative
No further information was able to be obtained from this customer regarding the system and the consumable product.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 event cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).
 
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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 Key8713360
MDR Text Key148459405
Report Number2028159-2019-01149
Device Sequence Number1
Product Code HQC
Combination Product (y/n)N
PMA/PMN Number
K121555
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 09/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number8065751763
Was Device Available for Evaluation? No
Date Manufacturer Received08/27/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
CUSTOM-PAK SURGICAL PROCEDURE PACK; CUSTOM-PAK SURGICAL PROCEDURE PACK
Patient Outcome(s) Other;
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