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

Model Number AU00T0

Device Problems Difficult to Insert (1316); Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/17/2021

Event Type  malfunction  

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 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.

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).

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
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• MDR Report Key: 11779481
• MDR Text Key: 249229108
• Report Number: 9612169-2021-00113
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00380652394963
• UDI-Public: 00380652394963
• Combination Product (y/n): N
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 05/03/2021
• Initial Date FDA Received: 05/05/2021
• Supplement Dates Manufacturer Received: 07/12/2021; 08/09/2021
• Supplement Dates FDA Received: 07/17/2021; 09/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PROVISC