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

Model Number	MA50BM
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Blurred Vision (2137); Insufficient Information (4580)
Date of Event	05/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported that after the intraocular lens implantation surgery, the sub surface nano glistenings (ssng) of the lens increased.Hence the lens was removed and replaced with another lens.Additional information was requested, but no further information is available.
Additional Manufacturer Narrative
The lens was returned in two pieces submerged in clear liquid in a vial placed inside a clear plastic bag labeled for the file.The lens was removed from the liquid and allowed to air dry prior to evaluation.One optic portion has a crack near the edge on the posterior surface.The other optic portion has a crack located near the edge on the posterior optic surface and directly opposite on the anterior optic surface.There were no immediate evidence of microvacuoles observed in the lens material when viewed through microscope at varying degrees of magnification.The lens was cleaned with klrp and then allowed to acclimate to room temperature in an open lens case to perform additional evaluation.After acclimating to the room temperature, the lens was re-evaluated for the reported complaint.The lens was clear with no visible evidence observed of microvacuoles/glistenings.A small amount of embedded microscopic particulate was observed and light scratches.Both consider cosmetic imperfections and would be acceptable per release criteria.Complaint history and product history records could not be reviewed because the reporter did not provide a lot number or any identification traceable to the manufacturing documentation.Associated product information was not provided.It is unknown if a qualified product combination was used.The company model is only qualified for use in the specific company cartridge.Root cause: the product investigation could not identify a root cause for the reported complaint.The explanted lens was cut into two portions and returned submerged in liquid.The lens was cleaned and allowed to acclimate to the room temperature.The lens was clear after acclimating.There was no evidence observed of the reported microvacuoles.The optic portions have a small amount of embedded tiny particulate and light scratches.Both of these cosmetic imperfections would meet current release criteria and would not impact the functionality of the lens.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 replacement lens model and diopter information was not provided.If additional information becomes available, the file will be reopened and updated.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Information provided in the file indicated that the lens was implanted in (b)(6) 2004.The lens was explanted nearly 19 years later in (b)(6) 2023.New information provided by the customer indicated that a patient visited in 2023 with decreased vision in the right eye.In the customer's opinion, since it was considered that it was related with intraocular lens (iol) glistening, iol removal and replacement was performed in the right eye on (b)(6) 2023.Since visual acuity was improved afterwards, it was considered to be caused by iol glistening.The file indicated that the company lens of 17.0 diopter was removed and replaced with a non-company lens that was 15.5 diopters.This difference in diopters between the initial implant and the replacement lens may suggest that the diopter of the replacement lens was an improved selection for this patient's current vision needs.If additional information becomes available, the file will be reopened and updated.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was requested and received stating that, a patient visited with decreased vision in the right eye.Since it was considered that it was related with lens glistening, lens removal and replacement was performed in the right eye.After the lens replacement visual acuity was improved.Hence it was considered to be caused by lens glistenings.

• Brand Name: ACRYSOF MULTIPIECE 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: 17126741
• Report Number: 1119421-2023-01113
• Device Sequence Number: 17742508
• Product Code: HQL
• UDI-Device Identifier: 00380650698476
• UDI-Public: 00380650698476
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2008
• Device Model Number: MA50BM
• Device Catalogue Number: MA50BM.170
• Device Lot Number: 786085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2023
• Supplement Date Received by Manufacturer: 06/23/2023
• Initial Report FDA Received Date: 06/14/2023
• Supplement Report FDA Received Date: 07/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2003
• 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: HOYA VA70AD 15.5D (REPLACEMENT LENS).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female