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 Activation, Positioning or Separation Problem (2906); Failure to Eject (4010)

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

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: 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 customer reported during the implant of an intraocular lens (iol) using a preloaded delivery system, the lens did not come out.There was patient contact and the procedure was completed using a backup lens.Additional information was requested.

Manufacturer Narrative

The product was not returned for analysis.The complainant indicates the use of a viscoelastic , which is not qualified for use with company preload device.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).

Manufacturer Narrative

Correction information submitted in h.6.(previously submitted fda device code 2338 incorrectly submitted).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 advanced just past the lens bay and is misfolded.A plunger override was observed.The manufacturer internal reference number is: (b)(4).

• 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
• 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: 11273649
• MDR Text Key: 231384814
• Report Number: 9612169-2021-00021
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 09/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: AU00T0
• Device Lot Number: 21271080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MICROVISC