• 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 ASPHERIC IOL WITH THE ULTRASERT PRE-LOADED DELIVERY SYSTEM; 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 LABORATORIES IRELAND LTD. ACRYSOF IQ ASPHERIC IOL WITH THE ULTRASERT PRE-LOADED DELIVERY SYSTEM; INTRAOCULAR LENS Back to Search Results
Model Number AU00T0
Device Problem Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/25/2021
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 nurse reported during the preparation of the iol while removing "the blue lens lock" the cartridge opened and exposed iol.It seemed like the small clip holding the lens chamber closed was loose.The surgery was delayed for a few minutes but was completed with a back up lens without any enlarged incisions nor any sutures were needed.There was no patient harm and the patient was ok.
 
Manufacturer Narrative
The product was returned for analysis and the reported damage was not observed.Additional observations were as follows: the device is returned loose in the carton.The lens stop and the plunger is present on the device.Viscoelastic is observed in the device.The lens bay door is closed securely - it closes and opens with no issues.The lens stop can be removed with no issues.We are unable to determine the root cause for the reported complaint "cartridge opened and exposed company lens".The device was returned with the lens bay door securely closed.No damage was observed to the returned device.The returned device shows evidence of possible handling by the customer due to the presence of solution dried in the device.All product and batch history records are quality reviewed prior to product release.The manufacturer internal reference number is: (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ACRYSOF IQ ASPHERIC IOL WITH THE ULTRASERT PRE-LOADED DELIVERY SYSTEM
Type of Device
INTRAOCULAR LENS
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 Key12870066
MDR Text Key281220700
Report Number9612169-2021-00274
Device Sequence Number1
Product Code HQL
UDI-Device Identifier00380652394727
UDI-Public00380652394727
Combination Product (y/n)N
Reporter Country CodeFI
PMA/PMN Number
P930014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/16/2022
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 Date01/07/2024
Device Model NumberAU00T0
Device Lot Number25129155
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/15/2021
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/01/2021
Initial Date FDA Received11/24/2021
Supplement Dates Manufacturer Received01/24/2022
Supplement Dates FDA Received02/16/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/07/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE.; DISCOVISC.
Patient SexFemale
-
-