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

Model Number	SA60WF
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	08/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample device was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A facility representative reported that during an intraocular lens (iol) implant procedure, it was noted that posterior capsule ruptured when dialing the lens.The iol was explanted during initial procedure.Lens was replaced with another model company lens.There was no patient harm.Additional information has been requested.
Additional Manufacturer Narrative
Correction information provided in d.4.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information provided in d.9., h.3., h.6.And h.11.The lens was returned inside a plastic specimen cup with a screw top lid.The lens was wrapped in white gauze material inside the specimen cup.Viscoelastic was dried on the lens.The lens was cleaned with klrp to evaluate.No damage was observed to the lens.A dimensional (plan view) inspection was conducted with the lens.The lens met specification per the approved template.Power and resolution were verified.The lens met specification for a company 23.5 diopter lens.Product history records were reviewed and documentation indicated the product met release criteria.Information was provided that indicated the use of a qualified cartridge, handpiece, and viscoelastic combination.The root cause cannot be determined for the reported complaint of posterior capsule ruptured when dialing the lens.The lens was returned and no damage was observed.A dimensional (plan view) inspection was conducted with the lens.The lens met specification per the approved template.Each lens is subjected to a 100 percent assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.Information was provided that indicated the company 23.5 diopter lens was removed and replaced with another model same company lens.The diopter of the replacement lens was not provided.Information was provided that the surgeon was unsure if the rupture was due to a lens issue or patient issue.The returned lens was undamaged and met specification, this suggests that the posterior capsule rupture would most likely not have been caused by a malfunction of the lens.File will be reopened if new information is received.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: 20266122
• Report Number: 1119421-2024-01865
• Device Sequence Number: 18233718
• Product Code: HQL
• UDI-Device Identifier: 00380652332736
• UDI-Public: (01)00380652332736(17)281022(11)231025(10)15740684(21)15740684041
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/12/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: SA60WF
• Device Catalogue Number: SA60WF.235
• Device Lot Number: 15740684
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/23/2024
• Supplement Date Received by Manufacturer: 09/20/2024; 11/14/2024
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 10/16/2024; 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2023
• 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: DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE.; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.; MONARCH III IOL DELIVERY SYSTEM, INJECTOR.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR
• Patient Sex: Female