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 Codes	Difficult to Insert (1316); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2021
Type of Reportable Event	Malfunction
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 healthcare professional reported that the intraocular lens (iol) did not come out of the cartridge properly during a cataract extraction with iol implantation procedure.The procedure was completed with a back-up iol.There was no patient harm.
Additional Manufacturer Narrative
Additional information was provided in d.9, h.3, h.6 and h.10 the product was returned for analysis and the reported complaint was observed.Additional observations were as follows: the device is returned loose in the carton.The lens stop and the plunger stop has been removed.The correct nozzle confirmed on the device.Viscoelastic is observed in the device.The plunger is advanced past mid nozzle and is advanced under the lens.The lens is in the lens bay and is misfolded.We are unable to determine the root cause for the reported complaint "lens did not come out of the cartridge properly".Plunger underride was observed.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
In previous report fda product problem code 1316 was reported incorrectly, the correct code should be 2920.

• 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: 11779481
• Report Number: 9612169-2021-00113
• Device Sequence Number: 11622325
• Product Code: HQL
• UDI-Device Identifier: 00380652394963
• UDI-Public: 00380652394963
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/01/2021

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: 10/31/2022
• Device Model Number: AU00T0
• Device Lot Number: 21255820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2021
• Initial Date Received by Manufacturer: 05/03/2021
• Supplement Date Received by Manufacturer: 07/12/2021; 08/09/2021
• Initial Report FDA Received Date: 05/05/2021
• Supplement Report FDA Received Date: 07/17/2021; 09/01/2021
• 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