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

Model Number SA60AT

Device Problems Defective Device (2588); Appropriate Term/Code Not Available (3191)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/28/2022

Event Type  malfunction  

Event Description

A materials manager reported that during a cataract extraction with an intraocular lens (iol) implant procedure, the lens would not load and kept moving around.Patient contact was observed and procedure was completed with another lens.Additional information was requested, but further no information was available.

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

Additional information was provided in a.1, a.2, a.3, b.5, d.10, e.1, e.4, and h.6 the manufacturer internal reference number is: (b)(4).

Event Description

Additional information was received stating there was no patient harm.It was reported that patient's issues were resolved.

Manufacturer Narrative

A non-qualified cartridge was indicated with a qualified cartridge and viscoelastic.The company, 33.0 diopter lens is only qualified for use in the company cartridge.The root cause for the reported loading issue may to be related to a failure to follow the ifu (instructions for use).The ifu (instructions for use) 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.Company foldable intraocular lenses are qualified for use with a company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF SINGLEPIECE 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: 16041759
• MDR Text Key: 308248136
• Report Number: 1119421-2022-02719
• Device Sequence Number: 1
• Product Code: HQL
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SA60AT
• Device Catalogue Number: SA60AT.330
• Device Lot Number: 15250697
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/01/2022
• Initial Date FDA Received: 12/23/2022
• Supplement Dates Manufacturer Received: 01/05/2023; 02/06/2023
• Supplement Dates FDA Received: 01/30/2023; 03/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DUOVISC; MONARCH III, CARTRIDGE D; MONARCH III, INJECTOR
• Patient Age: 73 YR
• Patient Sex: Female