MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - HUNTINGTON ACRYSOF IQ SINGLEPIECE IOL W/ULTRASERT DELIVERY SYSTEM; LENS, GUIDE, INTRAOCULAR

Model Number	AU00T0
Health Effect - Clinical Codes	Eye Injury (1845); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/13/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample device was not returned for analysis.Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.Additional information has been requested.(b)(4).
Event or Problem Description
A surgeon reported that during an intraocular lens (iol) implant procedure, the lens shot out of the injector and hit the iris ciliary body and angle structures of the eye causing bleeding that filled the anterior chamber.He tried to control the bleeding with ocular viscoelastic device, but was not successful.At that point he could not see the implant, so he had to remove the lens.He indicated that capsule rupture was possible, but he wasn't sure.Additional information was requested.
Additional Manufacturer Narrative
Product history and batch records were reviewed and documentation indicated the product met release criteria.There has been one other complaint reported for the indicated lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
In a follow up, the surgeon reported that the incision was enlarged.The patient has an anterior chamber iol in the eye.The event is ongoing and he continues to manage the patient's follow up care.

• Brand Name: ACRYSOF IQ SINGLEPIECE IOL W/ULTRASERT DELIVERY SYSTEM
• Common Device Name: LENS, GUIDE, INTRAOCULAR
• Manufacturer (Section D): ALCON RESEARCH, LTD. - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LTD. - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: rita lopez ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514846
• MDR Report Key: 5884615
• Report Number: 1119421-2016-01173
• Device Sequence Number: 1387410
• Product Code: KYB
• UDI-Device Identifier: 00380652358286
• UDI-Public: 00380652358286
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2018
• Device Model Number: AU00T0
• Device Catalogue Number: AU00T0.205
• Device Lot Number: 12428225
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2016
• Supplement Date Received by Manufacturer: 08/29/2016
• Initial Report FDA Received Date: 08/17/2016
• Supplement Report FDA Received Date: 11/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: BSS; PROVISC; VISCOAT
• Outcome Attributed to Adverse Event: Other
• Patient Age: 68 YR
• Patient Sex: Female