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

Model Number MA60AC

Device Problem Break (1069)

Patient Problems Corneal Edema (1791); Visual Impairment (2138); Eye Pain (4467); Unspecified Eye / Vision Problem (4471)

Event Date 11/28/2023

Event Type  Injury  

Event Description

A healthcare professional reported that, during intraocular lens implantation surgery, the lens was implanted and the haptic that was outside was separated.So the lens was removed.Subsequently there was a marked miosis and corneal edema that did not allow the surgeon to see the edge of the rhexis, so the placement of the new lens was postponed.During follow up visit, the patient reported that, he has reported poorly modulated pain and visual acuity impairment.Additional information was received stating that additional surgical procedure for the implantation of the new lens was scheduled on december 16 and the new lens was implanted without any complications.

Manufacturer Narrative

The lens was returned for evaluation.Solution is dried on the lens.One haptic is broken in the haptic insertion area (not returned).The optic is split/cracked from the edge across the center of the optic.Cracks and a gouge mark are observed on the optic.Product history records were reviewed and the documentation indicated the product met release criteria.The file indicates the use of a non-qualified cartridge.Two viscoelastic were indicated but only one is qualified with a qualified cartridge and handpiece combination.The handpiece was not provided.The company model is only qualified for use in the company model cartridges.Broken haptic damage was observed.The root cause is most likely a failure to follow the ifu (instructions for use).The account used an unqualified lens/company combination.The company model is only qualified for use in the company model cartridges.Company foldable iols are qualified for use with an company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The ifu instructs that an 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.A replacement lens was implanted without complication.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: 18629778
• MDR Text Key: 334422030
• Report Number: 1119421-2024-00179
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00380652552523
• UDI-Public: 00380652552523
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MA60AC
• Device Catalogue Number: MA60AC.200
• Device Lot Number: 15484826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DUOVISC; KELLMAN CLAMP; MONARCH III CARTRIDGE D
• Patient Outcome(s): Required Intervention