• 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 ASPHERIC UV ABSORBING SINGLEPIECE 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 ASPHERIC UV ABSORBING SINGLEPIECE IOL; INTRAOCULAR LENS Back to Search Results
Model Number SA60WF
Device Problem Structural Problem (2506)
Patient Problem No Patient Involvement (2645)
Event Date 05/14/2019
Event Type  malfunction  
Manufacturer Narrative
Evaluation summary: the product was not returned for analysis.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.(b)(4).
 
Event Description
A facility representative reported that during an intraocular lens (iol) implant procedure, when folding the lens, it felt brittle and also had a weird curl on the middle of the lens.There was no patient contact and the procedure was completed with a new lens.Additional information was requested.
 
Manufacturer Narrative
Product evaluation: the lens was returned positioned incorrectly in the lens case.Solution is dried on the lens.The optic edge has two areas that have small gouged damaged.The posterior surface of the optic has scratches.The reported "curl" shape was not observed.The lens was cleaned with lphse to further assess.The lens did not appear to be brittle.The optic and the haptics are pliable when manipulated.A fold test was conducted using folding tweezers.The lens folded and unfolded with no abnormalities observed.The product investigation could not identify a root cause for the complaint of "when folding lens, it felt brittle; also had a weird curl on the middle of lens".The manufacturer internal reference number is: (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ACRYSOF ASPHERIC UV ABSORBING SINGLEPIECE IOL
Type of Device
INTRAOCULAR LENS
Manufacturer (Section D)
ALCON RESEARCH, LLC - HUNTINGTON
6065 kyle lane
huntington WV 25702
MDR Report Key8707896
MDR Text Key148647331
Report Number1119421-2019-00944
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 09/23/2019
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 Date03/31/2023
Device Model NumberSA60WF
Device Catalogue NumberSA60WF.225
Device Lot Number12609091
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/25/2019
Initial Date Manufacturer Received 05/22/2019
Initial Date FDA Received06/18/2019
Supplement Dates Manufacturer Received08/29/2019
Supplement Dates FDA Received09/23/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-