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

Model Number	SN6AT3
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/22/2023
Type of Reportable Event	Malfunction
Additional 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.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A nurse reported about a lens damage detected during intraocular implantation procedure.The surgery was completed with an another lens.No further information expected as reporter unwilling to provide additional information.
Additional Manufacturer Narrative
The product was not returned.A photo was available in the file.The image shows a magnified view of the lens positioned on the post of the lens case lid.The lens optic and haptics were broken.One haptic was broken in the distal area.The other haptic appeared to be broken in the gusset area.The side of the optic was broken and crushed.A dark shadowed area was seen in the image.It is unknown if the shadow area is a dried solution, dried blood, or an anomaly of the photograph.Based on our observation of the attached photo, the lens is damaged.The image showed a dark shadowed area.It is unknown if the shadow area is a dried solution, dried blood, or an anomaly of the photograph.It is difficult to make a determination of handling / damage without evaluation of the physical sample.A final root cause cannot be determined based on available information.File will be reopened when new information or the product is received.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was provided stating the left eye was involved.
Additional Manufacturer Narrative
Only a portion of a damaged lens was returned in the lens case in the lens carton.The damaged portion of optic was crushed and scraped, typical in appearance to damage from posts of the lens case.A photo was provided that showed the entire lens.The optic was crushed and torn on the large post of the lens case lid and the haptics were broken, typical of damage from the posts of the lens case.Product history records were reviewed and the documentation indicated the product met release criteria.Based on the returned sample and provided photo, the lens was damaged.Due to the absence of clinical solution on the returned sample the root cause is potentially manufacturing related.If the lens becomes misaligned in the lens case, lens damage may occur.The manufacturer internal reference number is: (b)(4).

• 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
• 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: 17342532
• Report Number: 1119421-2023-01276
• Device Sequence Number: 17777985
• Product Code: MJP
• UDI-Device Identifier: 00380652249928
• UDI-Public: 00380652249928
• Combination Product (Y/N): N
• Initial Reporter Country: LO
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/06/2023

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 Model Number: SN6AT3
• Device Catalogue Number: SN6AT3.215
• Device Lot Number: 15535410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/23/2023
• Supplement Date Received by Manufacturer: 08/13/2023; 09/15/2023
• Initial Report FDA Received Date: 07/18/2023
• Supplement Report FDA Received Date: 09/07/2023; 10/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2022
• 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
• Patient Sex: Unknown