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

Model Number	SA60AT
Medical Device Problem Codes	Defective Device (2588); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2022
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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).
Additional 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 or Problem Description
Additional information was received stating there was no patient harm.It was reported that patient's issues were resolved.
Additional 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
• Common Device Name: 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
• Report Number: 1119421-2022-02719
• Device Sequence Number: 20057736
• Product Code: HQL
• UDI-Device Identifier: 00380650141293
• UDI-Public: 00380650141293
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 08/18/2026
• Device Model Number: SA60AT
• Device Catalogue Number: SA60AT.330
• Device Lot Number: 15250697
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/01/2022
• Supplement Date Received by Manufacturer: 01/05/2023; 02/06/2023
• Initial Report FDA Received Date: 12/23/2022
• Supplement Report FDA Received Date: 01/30/2023; 03/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DUOVISC; MONARCH III, CARTRIDGE D; MONARCH III, INJECTOR
• Patient Age: 73 YR
• Patient Sex: Female