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

Model Number MA60MA

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Intraocular Pressure Increased (1937); Visual Impairment (2138)

Event Date 12/07/2021

Event Type  Injury  

Manufacturer Narrative

A sample device was not returned for analysis.Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.(b)(4).

Event Description

A physician reported that following an intraocular lens (iol) implant procedure, the patient's intraocular pressure (iop) was elevated for which drops were provided.The iol decreased later on.Approximately 3 weeks after surgery, the patient had sudden loss of vision which was noted upon awakening.There was change in the best corrected vision and the corneal top markedly different from pre operative with 3.2 d astigmatism (appears eccentric with more astigmatism inferior to point of fixation) at axis 106.Additional information has been requested.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Event Description

Additional information has been requested and received stating patient was happy with the result of surgery despite the astigmatism.

Manufacturer Narrative

The product was not returned.Product history records were reviewed and documentation indicated the product met release criteria.The associated cartridge indicated is not qualified for this lens model; however, it would not be related to the reported events.The product investigation could not identify a root cause for the reported complaint.Each lens is subjected to a 100% assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.The information provided indicated there was a sudden change in the astigmatism at day 20.The complaint lens does not have a cylinder component.The non-toric monofocal iol would not be a likely cause of an astigmatism issue manifesting 20 days post-operatively.Pre-existing conditions provided indicated the od glaucoma was associated with ocular trauma.Further information was provided that the patient is happy with the results despite the change in astigmatism.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: 13118229
• MDR Text Key: 282966220
• Report Number: 1119421-2021-02510
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00380650699282
• UDI-Public: 00380650699282
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MA60MA
• Device Catalogue Number: MA60MA.050
• Device Lot Number: 15207288
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DUOVISC OVD.; MONARCH III CARTRIDGE D.; MONARCH III INJECTOR.
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male