MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM; INTRAOCULAR LENS

Model Number AU00T0

Device Problem Difficult to Advance (2920)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/01/2022

Event Type  Injury  

Event Description

Another health care professional reported that during an intraocular lens (iol) implant procedure, the back haptic was stuck in introducer.Faulty lens removed, which caused some bleeding in eye.This was switched & new lens was inserted.Additional information has been requested.

Manufacturer Narrative

A sample device was not returned for analysis.Product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

A non-qualified viscoelastic was indicated.The root cause may be related to a failure to follow the instructions for use (ifu).A non-qualified viscoelastic was used in the device.Material properties of non-qualified ophthalmic viscoelastic devices (ovd) may contribute to underfill, overfill, misfolding of the haptics, or other inconsistent folding outcomes.The ifu instructs: during device preparation and implantation of the company lens iol with the company device preloaded delivery system, an company qualified ophthalmic viscoelastic device (ovd) should be used.The use of an unqualified ovd 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 SINGLEPIECE IOL WITH 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: 14487543
• MDR Text Key: 292491416
• Report Number: 1119421-2022-01110
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00380652394819
• UDI-Public: 00380652394819
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AU00T0
• Device Lot Number: 15307831
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: HEALON VISCOELASTIC.
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Sex: Female