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

MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. ACRYSOF IQ TORIC SINGLEPIECE IOL LENS, INTRAOCULAR, TORIC OPTICS

  • 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 LABORATORIES IRELAND LTD. ACRYSOF IQ TORIC SINGLEPIECE IOL LENS, INTRAOCULAR, TORIC OPTICS Back to Search Results
Model Number SN6AT3
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/11/2021
Event Type  malfunction  
Manufacturer Narrative
A sample device was not returned for analysis. Complaint history and product history records were reviewed and documentation indicated the product met release criteria. Root cause has not been identified. 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 that during intraocular lens (iol) implant procedure, the lens was split in half after insertion. The lens was removed and replaced and procedure completed. Additional information was requested and received stating, the capsular bag was intact so lens replaced with another lens of same power. Patient doesn¿t foresee any ongoing concerns.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameACRYSOF IQ TORIC SINGLEPIECE IOL
Type of DeviceLENS, INTRAOCULAR, TORIC OPTICS
Manufacturer (Section D)
ALCON LABORATORIES IRELAND LTD.
cork business&technology park
model farm road
cork 00000
EI 00000
Manufacturer (Section G)
ALCON LABORATORIES IRELAND LTD.
cork business&technology park
model farm road
cork 00000
EI 00000
Manufacturer Contact
jonathan schlech
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8007579780
MDR Report Key12388271
MDR Text Key268978164
Report Number9612169-2021-00178
Device Sequence Number1
Product Code MJP
UDI-Device Identifier00380652249904
UDI-Public00380652249904
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
P930014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Administrator/Supervisor
Type of Report Initial,Followup
Report Date 01/12/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSN6AT3
Device Catalogue NumberSN6AT3.205
Device Lot Number21258373
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/01/2021
Date Manufacturer Received12/22/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/04/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-