• 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 - HUNTINGTON ACRYSOF MULTIPIECE IOL; INTRAOCULAR LENS

  • 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 - HUNTINGTON ACRYSOF MULTIPIECE IOL; INTRAOCULAR LENS Back to Search Results
Model Number MA60AC
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Evaluation summary: the product was not returned for analysis.The product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
 
Event Description
A facility representative reported via an intraocular lens (iol) implant reply card that the lens was damaged, not implanted.Additional information has been requested.
 
Event Description
Additional information was provided indicating that the lens was found in a warmer at 120 degrees for an unknown length of time.The issue was not observed upon opening, or during loading or during the surgery.The iol sample was destroyed on the site so it is not available for return.
 
Manufacturer Narrative
H.10.: based on information received following submission of the initial report, this event does not meet criteria for reporting as a device malfunction.The manufacturer internal reference number is: (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ACRYSOF MULTIPIECE IOL
Type of Device
INTRAOCULAR LENS
Manufacturer (Section D)
ALCON RESEARCH, LLC - HUNTINGTON
6065 kyle lane
huntington WV 25702
MDR Report Key10680217
MDR Text Key213412363
Report Number1119421-2020-01470
Device Sequence Number1
Product Code HQL
Combination Product (y/n)N
PMA/PMN Number
P930014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 12/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2022
Device Model NumberMA60AC
Device Catalogue NumberMA60AC.165
Device Lot Number12532318
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/23/2020
Initial Date FDA Received10/14/2020
Supplement Dates Manufacturer Received12/04/2020
Supplement Dates FDA Received12/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-