MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH ULTRASERT DELIVERY SYSTEM; INTRAOCULAR LENS

Model Number ACU0T0

Device Problems Failure to Unfold or Unwrap (1669); Appropriate Term/Code Not Available (3191)

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

Event Date 09/24/2022

Event Type  malfunction  

Event Description

A health care professional reported that during an intraocular lens (iol) implant procedure, lens wasn't folded properly in the delivery system and didn't open correct way in the eye.The procedure was completed by using another lens.There was no patient harm.

Manufacturer Narrative

A sample device was not returned for analysis.Complaint and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been 4 other complaints reported in the lot the manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Only the used device was returned loose in the carton.The plunger lock and the lens stop were removed.The plunger was oriented correctly.Viscoelastic was observed, in the device.The plunger was retracted to mid-nozzle.No damage was observed, to the device.The lens was not returned.A qualified viscoelastic was indicated.The root cause could not be determined, for the reported complaint.Only the used device was returned.No damage was observed, to the device.The plunger was retracted.The plunger position in relation to the lens, during advancement cannot be determined.It is unknown, if the lens and plunger were in acceptable positions, per the ifu (instructions for use).The ifu instructs: after the lens has been advanced to the nozzle line, the lens should be visually inspected to determine, the position of the haptics.The plunger should be in contact with the trailing optic edge.After confirming, the lens is properly positioned and the haptics are folded properly, proceed with lens implantation.Proceeding with implantation of a misfolded haptic or a lens that appears to be ¿out of position¿ can result in a broken haptic or other negative outcome, since the haptic may be trapped and stretched, and/or pinched and sheared by the moving plunger.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH ULTRASERT DELIVERY SYSTEM
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 15657956
• MDR Text Key: 306919073
• Report Number: 1119421-2022-02261
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00380652395281
• UDI-Public: 00380652395281
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ACU0T0
• Device Lot Number: 15418991
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PROVISC