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

Model Number	SN6AT3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Headache (1880); Intraocular Pressure Increased (1937); Visual Impairment (2138); Eye Pain (4467)
Date of Event	08/11/2021
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 optician reported that after one day of an intraocular lens (iol) implant procedure the patient experienced headache, eye pain and had tension post-op 54 mmhg.Hcp performed a pressure relief via paracentesis and later explanted the iol.Additional information was requested.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was requested and received.Patient diagnosis with eye pressure elevation and myopia.The events outcome was unchanged.Due to events unscheduled medical treatment pars plana vitrectomy was performed.As per health care professional cause of event was flat anterior chamber.Flat anterior chamber was there due to strabismus surgery at patient age 5.
Additional Manufacturer Narrative
The product was returned for analysis.Iol case returned opened in an unknown sealed peel pouch, adhered to unknown blister tray.A significant amount of solution is dried on both surfaces of the optic and haptics.Both haptics are intact.The optic is torn/split-cut and scratched/marked-rejectable.We are unable to determine the root cause for the reported complaint "explantation due to tension ".The returned iol shows evidence of possible handling by the customer due to the presence of solution dried on both surfaces of the optic and haptics.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.All product and batch history records are quality reviewed prior to product release.There have been no other complaints for this lot.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 ; 8175514979
• MDR Report Key: 12388495
• Report Number: 9612169-2021-00179
• Device Sequence Number: 3476118
• Product Code: MJP
• UDI-Device Identifier: 00380652250023
• UDI-Public: 00380652250023
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2024
• Device Model Number: SN6AT3
• Device Catalogue Number: SN6AT3.265
• Device Lot Number: 21260282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/12/2021
• Supplement Date Received by Manufacturer: 08/27/2021; 11/15/2021
• Initial Report FDA Received Date: 08/30/2021
• Supplement Report FDA Received Date: 09/21/2021; 11/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2019
• 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 CARTRIDGE C; MONARCH IOL INJECTOR, UNSPECIFIED; Z HYALIN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female