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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ TORIC SINGLEPIECE IOL; LENS, INTRAOCULAR, TORIC OPTICS

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ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ TORIC SINGLEPIECE IOL; LENS, INTRAOCULAR, TORIC OPTICS Back to Search Results
Model Number SN6AT3
Device Problem Failure to Unfold or Unwrap (1669)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/12/2021
Event Type  malfunction  
Manufacturer Narrative
Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
 
Event Description
A healthcare professional reported that during an intraocular lens (iol) procedure, the iol was defective, did not unfold.The iol was replaced with a back-up lens.Patient harm was not reported.
 
Manufacturer Narrative
Product evaluation: the lens was returned positioned incorrectly in the lens case.Solution was dried on the lens.One haptic was bent in the gusset and distal.The other haptic was broken in the distal tip area (not returned).The optic was cut into pieces, typical of insertion and removal.A fold inspection could not be conducted due to extensive lens damage.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Qualified associated products were indicated.The product investigation could not identify a root cause for the reported event.A fold inspection could not be conducted due to extensive lens damage.The manufacturer internal reference number is: (b)(4).
 
Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
 
Event Description
Additional information received, indicated that the device was in contact with the patient's eye.The event occurred, during the progression of the implant in the cartridge.There was no patient consequences.
 
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Brand Name
ACRYSOF IQ TORIC SINGLEPIECE IOL
Type of Device
LENS, INTRAOCULAR, TORIC OPTICS
Manufacturer (Section D)
ALCON RESEARCH, LLC - HUNTINGTON
6065 kyle lane
huntington WV 25702
MDR Report Key11634411
MDR Text Key244426476
Report Number1119421-2021-00775
Device Sequence Number1
Product Code MJP
UDI-Device Identifier00380652249881
UDI-Public00380652249881
Combination Product (y/n)N
PMA/PMN Number
P930014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup,Followup
Report Date 06/15/2021
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 Model NumberSN6AT3
Device Catalogue NumberSN6AT3.195
Device Lot Number15021155
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/19/2021
Initial Date Manufacturer Received 03/17/2021
Initial Date FDA Received04/08/2021
Supplement Dates Manufacturer Received04/13/2021
05/24/2021
Supplement Dates FDA Received05/05/2021
06/15/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
MONARCH IOL CARTRIDGE D; MONARCH IOL INJECTOR
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