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

Model Number	SA60WF
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 or Problem Description
A physician assistant reported that during a cataract extraction with intraocular lens (iol) implant procedure, the string was found on the lens and was removed by irrigation and aspiration.The surgery was completed by using new medical device.No further information available.Additional information received stated that lens was not removed and all the lenses remained inside the eye.
Additional Manufacturer Narrative
The product was not returned, the lens remained implanted.A vial identified for this file was received.The vial was labeled "voor weefselconserving formaldehyde 4% gebufferd".A small, clear linear particle was observed floating in the liquid.The particle was sent to the particle lab for testing.The lab results were provided.The sample container was visually and microscopically examined and the reported foreign material was observed.Microscopic examination shows a clear particle approximately 1.3mm in length.The clear particle was then isolated and analyzed using microscopic fourier transform infrared spectroscopy (micro ft-ir).Comparison of the clear particle¿s generated spectra to a library of spectra found the best match to company cartridge base coat.Iol product history records were reviewed, and documentation indicated the product met release criteria.A qualified cartridge and viscoelastic were indicated.The handpiece used was not provide.It is unknown if a qualified handpiece was used.The root cause could not be determined.The reported "string" was returned.The returned particle was evaluated by the particle lab.The associated company cartridge was not returned for evaluation.It cannot be determined if the company cartridge was damaged during the lens delivery.The handpiece used was not indicated.It is unknown if a qualified product was used.Per the ifu: company foldable iols are qualified for use with an company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The use of an unqualified combination may cause damage to the iol and potential complications during the implantation process.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
A qualified cartridge, handpiece and viscoelastic were indicated.The instruction for use ifu instructs to completely fill the cartridge with ovd immediately prior to loading and delivery of the lens.Do not attempt to load the lens without adequate ovd in the device.Not adequately filling the device with viscoelastic will result in inadequate coverage of lens and the lens fold path with ovd, which may result in damage.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF ASPHERIC UV ABSORBING 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: 14249861
• Report Number: 1119421-2022-00901
• Device Sequence Number: 11873559
• Product Code: HQL
• UDI-Device Identifier: 00380652332705
• UDI-Public: 00380652332705
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/18/2023

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: 05/02/2026
• Device Model Number: SA60WF
• Device Catalogue Number: SA60WF.220
• Device Lot Number: 15196806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/05/2022
• Supplement Date Received by Manufacturer: 06/03/2022; 12/21/2022
• Initial Report FDA Received Date: 04/29/2022
• Supplement Report FDA Received Date: 06/29/2022; 01/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/04/2021
• 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: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.; MONARCH III IOL DELIVERY SYSTEM, INJECTOR.; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE.
• Patient Sex: Unknown