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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

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ALCON LABORATORIES IRELAND LTD. ACRYSOF IQ TORIC SINGLEPIECE IOL LENS, INTRAOCULAR, TORIC OPTICS Back to Search Results
Model Number SN6AT5
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/23/2022
Event Type  malfunction  
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. Complaint history and product history records were reviewed, and documentation indicated the product met release criteria. There have been no other complaints reported in the lot number. The manufacturer internal reference number is: (b)(4).
 
Event Description
An inventory management specialist reported that during an intraocular lens (iol) implant procedure, a torn lens was noted with patient contact. Additional information was received stating there was no patient harm and surgery completed on same day.
 
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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 Key14787705
MDR Text Key295801093
Report Number9612169-2022-00293
Device Sequence Number1
Product Code MJP
UDI-Device Identifier00380652250856
UDI-Public00380652250856
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P930014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 09/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/23/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2022
Device Model NumberSN6AT5
Device Catalogue NumberSN6AT5.130
Device Lot Number21204239
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer06/14/2022
Date Manufacturer Received08/18/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/02/2017
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/23/2022 Patient Sequence Number: 1
Treatment
MONARCH III CARTRIDGE D; PROVISC; UNSPECIFIED INJECTOR
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