MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF MULTIPIECE IOL; INTRAOCULAR LENS

Model Number MA60AC

Device Problems Defective Component (2292); Device Dislodged or Dislocated (2923)

Patient Problems Headache (1880); Eye Pain (4467)

Event Date 08/30/2023

Event Type  malfunction  

Manufacturer Narrative

The product was returned for analysis.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 facility representative reported that following an intraocular lens (iol) implant procedure, findings on both follow up visits showed well centered iol, clear cornea & corneal suture in place on operated eye.The patient came with complain of head ache and pain on the operated eye.After the examination, the surgeon found out that the haptic slipped from the junction on optic.Additional information has been requested, received and stated explant was planned.

Manufacturer Narrative

The product was not returned.Product history records were reviewed and documentation indicated the product met release criteria.A non-company viscoelastic was indicated.A cartridge and handpiece were not indicated.It is unknown if a delivery system was used or if the lens was manually implanted.The product investigation could not identify a root cause for the reported complaint.A determination cannot be made without physical examination of the product.The company 30.0 diopter lens is qualified for use with the company cartridges.The instruction for use (ifu) instructs that a company qualified delivery system and viscoelastic combination should be used.The use of an unqualified combination may cause damage to the lens and potential complications during the implantation process.The reporter has not responded to the follow up requests.The file will be reopened if the sample or new information is received.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF MULTIPIECE IOL
• 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: 17874832
• MDR Text Key: 324961566
• Report Number: 1119421-2023-01708
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00380652552721
• UDI-Public: 00380652552721
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MA60AC
• Device Catalogue Number: MA60AC.300
• Device Lot Number: 15505334
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: OPHLINE 2%