• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 Capsular Bag Tear (2639)
Event Date 12/07/2020
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.The manufacturer internal reference number is: (b)(4).
 
Event Description
A customer reported that during a cataract procedure, after insertion of the intraocular lens (iol), in the right eye, the surgeon observed a rupture in the capsule bag.The iol was removed, an anterior vitrectomy was performed, and a multi-piece iol was placed in the sulcus.The wound was sutured.The cause of the rupture is unknown.
 
Manufacturer Narrative
No further information was able to be obtained from this customer.With no additional related information provided, the customers reported event was not able to be confirmed.The manufacturing device history record (dhr) was reviewed.Based on qa assessment, the product met specifications at the time of release.The root cause could not be determined conclusively.The manufacturer internal reference number is: (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key11071780
MDR Text Key223587990
Report Number2028159-2020-01149
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 company representative,health
Type of Report Initial,Followup
Report Date 03/19/2021
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 Catalogue Number8065751763
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/07/2020
Initial Date FDA Received12/24/2020
Supplement Dates Manufacturer Received03/15/2021
Supplement Dates FDA Received03/19/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ORA VPLUS ABERROMETER; ORA W VERIFEYE PLUS SURG CART; ORA VPLUS ABERROMETER; ORA W VERIFEYE PLUS SURG CART
Patient Outcome(s) Required Intervention;
-
-