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	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/03/2021
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.(b)(4).
Event or Problem Description
A facility representative reported that the "lens was stuck" during a right eye intraocular lens implantation procedure.A back-up device was used to complete the procedure.There was no patient harm.
Additional Manufacturer Narrative
The previous report submitted for this event contained an error in h.1.- ¿summary report¿ was inadvertently selected.After a recent systems update, a system error caused the inadvertent additional selection of ¿summary report¿ in h.1.On a select number of reports.The error, which was limited only to the h.1.Field, was promptly identified and quickly rectified.Correction smdrs are being filed for the impacted reports.This smdr is correcting that error for this event.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Product evaluation: the product was not returned for analysis.The complainant indicates the use of a viscoelastic, which is not qualified for use with the company device.Root cause: the reported complaint was not observed as no sample was returned for analysis; however, based on the information provided by the customer, the most likely root cause is failure to follow dfu, as the surgeon states the use of non-qualified viscoelastic.Lens delivery performance may be negatively affected when using other non-qualified viscoelastics leading to underfill, overfill, misfolding , delivery issues and /or damage.All product and batch history records are quality reviewed prior to product release.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information provided in d.9, h.3, h.6, and h.10.The product was returned for analysis and the reported complaint was observed.The device was returned in a plastic bag inside the carton.The lens stop and the plunger stop have been removed.The plunger is oriented correctly.Viscoelastic is dried in the device.The plunger has been advanced into the mid nozzle and is advanced over the lens.The lens is in the lens bay and is misfolded.A plunger override was observed.The root cause may be related to failure to follow the ifu(instructions for use), as the customer states the use of non-qualified viscoelastic.The use of an unqualified ovd(ophthalmic visco surgical device) may cause damage to the lens and potential complications during the device preparation and implantation steps.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
• 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: 11399978
• Report Number: 9612169-2021-00050
• Device Sequence Number: 14578485
• Product Code: HQL
• UDI-Device Identifier: 00380652394703
• UDI-Public: 00380652394703
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/08/2022

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: 02/28/2023
• Device Model Number: AU00T0
• Device Lot Number: 21266567
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 02/09/2021
• Supplement Date Received by Manufacturer: 03/03/2021; 04/28/2021; 08/16/2022
• Initial Report FDA Received Date: 03/02/2021
• Supplement Report FDA Received Date: 03/15/2021; 05/21/2021; 09/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2020
• 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: MICROVISC; MICROVISC
• Patient Age: 79 YR
• Patient Sex: Female