MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. ACRYSOF IQ TORIC SINGLEPIECE IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	SN6AT3
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2021
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.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A facility representative reported that during intraocular lens (iol) implant procedure, the lens was split in half after insertion.The lens was removed and replaced and procedure completed.Additional information was requested and received stating, the capsular bag was intact so lens replaced with another lens of same power.Patient doesn¿t foresee any ongoing concerns.
Additional Manufacturer Narrative
The product was returned for analysis and the reported damage was observed.Iol returned in three pieces adhered with dried solution to an unlabeled specimen container.Solution is dried on the iol.Backing paper adhered to iol, iol cleaned to facilitate further evaluation on the reported complaint.The haptics are intact.The optic is torn/split-cut dividing the iol in three(3) and scratched/marked-rejectable.We are unable to determine the root cause for the reported complaint "lens split in half after inserted".The returned iol shows evidence of possible handling by the customer due to the presence of solution dried on both surfaces.In addition to this, all iols are 100% cosmetically inspected as per approved manufacturing procedures and the observed lens damage would not meet our current release criteria.Based on these investigation findings, we are unable to verify if the iol contributed to the event.All product and batch history records are quality reviewed prior to product release.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 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 Key: 12388271
• Report Number: 9612169-2021-00178
• Device Sequence Number: 3476117
• Product Code: MJP
• UDI-Device Identifier: 00380652249904
• UDI-Public: 00380652249904
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2022

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: 10/31/2024
• Device Model Number: SN6AT3
• Device Catalogue Number: SN6AT3.205
• Device Lot Number: 21258373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/11/2021
• Supplement Date Received by Manufacturer: 12/22/2021
• Initial Report FDA Received Date: 08/30/2021
• Supplement Report FDA Received Date: 01/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2019
• 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: MONARCH III IOL CARTRIDGE D
• Patient Sex: Unknown