MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. ACRYSOF IQ ASPHERIC IOL WITH THE ULTRASERT PRE-LOADED DELIVERY SYSTEM; INTRAOCULAR LENS

Model Number	AU00T0
Medical Device Problem Code	Inaccurate Delivery (2339)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product evaluation: complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.No other complaints reported in the lot.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
The representative reported that they have experienced issues with the injectors riding over the iol.Additional information has been requested.
Additional Manufacturer Narrative
Additional information provided in h.6.H.3.D.9.D.10.And h.10.The product was returned for analysis and the reported complaint could not be observed.Iol was returned outside the device.The device was returned in the blister tray inside the carton.The lens stop and the plunger stop have been removed.The plunger is oriented correctly.Viscoelastic is observed in the device.The plunger has been retracted into the mid nozzle.No damage observed to the device.The iol is attached to the nozzle tip with solution.The lens is scratched/marked-rejectable.The product investigation could not identify the root cause for the reported complaint "injector riding over the iol" as lens was returned outside the device.Due to this, we are unable to confirm lens and haptic position for advancement and determine a root cause.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ ASPHERIC IOL WITH THE ULTRASERT PRE-LOADED DELIVERY SYSTEM
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• MDR Report Key: 11777696
• Report Number: 9612169-2021-00107
• Device Sequence Number: 19692304
• Product Code: HQL
• UDI-Device Identifier: 00380652394734
• UDI-Public: 00380652394734
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2021

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: 04/30/2023
• Device Model Number: AU00T0
• Device Lot Number: 21272175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2021
• Initial Date Received by Manufacturer: 04/07/2021
• Supplement Date Received by Manufacturer: 07/27/2021
• Initial Report FDA Received Date: 05/05/2021
• Supplement Report FDA Received Date: 08/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PROVISC; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE; PROVISC