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

Model Number	SN6AT3
Medical Device Problem Code	Failure to Unfold or Unwrap (1669)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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).
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Event or Problem 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.

• Brand Name: ACRYSOF IQ TORIC SINGLEPIECE IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 11634411
• Report Number: 1119421-2021-00775
• Device Sequence Number: 17058327
• Product Code: MJP
• UDI-Device Identifier: 00380652249881
• UDI-Public: 00380652249881
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 02/08/2025
• Device Model Number: SN6AT3
• Device Catalogue Number: SN6AT3.195
• Device Lot Number: 15021155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2021
• Initial Date Received by Manufacturer: 03/17/2021
• Supplement Date Received by Manufacturer: 04/13/2021; 05/24/2021
• Initial Report FDA Received Date: 04/08/2021
• Supplement Report FDA Received Date: 05/05/2021; 06/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MONARCH IOL CARTRIDGE D; MONARCH IOL INJECTOR