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

Model Number	SA6AT4
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	01/26/2023
Type of Reportable Event	Serious Injury
Additional 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.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A health care professional reported that following an intraocular lens (iol) implant procedure, the patient experienced super blurred vision.Clinical reason for explant mentioned as dislocated intraocular lens (iol).The iol was explanted and exchanged for an unknown atiol following the secondary implant procedure.Additional information received, there was no patient harm.
Additional Manufacturer Narrative
Additional information has been provided in h.3., h.6., and h.11.The product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.Information was provided that a qualified cartridge and handpiece were used.It is unknown if a qualified viscoelastic was used.The product investigation could not identify a root cause for the reported complaint.The product was not returned.Each lens is subjected to a 100% assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.The company (2.25 cyl.) 22.5 diopter lens was removed and replaced with a company (6.00 cy.) 23.0 diopter lens.This information that the exchange was from an company (2,25 cyl.) to a much larger cylinder lens model company (6.00 cyl.) 23.0 diopter may suggest that the replacement lens model may be an improved selection for this patient vision needs.Due diligence has been performed in an attempt to obtain further information on this event.The reporter has not responded to request for follow-up information.File will be reopened if new information or the sample is received.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Corrected information provided in b5.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been received and stated the iol was explanted and exchanged for a different model lens following the secondary implant procedure.There was no patient harm.

• Brand Name: ACRYSOF TORIC ASPHERIC UV ABSORBING SINGLEPIECE IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 19690579
• Report Number: 1119421-2024-01281
• Device Sequence Number: 15547561
• Product Code: HQL
• UDI-Device Identifier: 00380652336345
• UDI-Public: (01)00380652336345(17)270816(11)220818(10)15472467(21)15472467005
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/15/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: SA6AT4
• Device Lot Number: 15472467
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/10/2024
• Supplement Date Received by Manufacturer: 08/19/2024; 09/17/2024
• Initial Report FDA Received Date: 07/08/2024
• Supplement Report FDA Received Date: 09/17/2024; 10/15/2024
• Date Device Manufactured: 08/18/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ACRYSOF TORIC ASP UV ABSORBING SINGLE PIECE IOL.; MONARCH III IOL CARTRIDGE D.; MONARCH III IOL INJECTOR.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female