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

Model Number	SA60WF
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	08/27/2024
Type of Reportable Event	Serious Injury
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 healthcare professional reported that during cataract surgery with intraocular lens (iol) implant procedure, lens was unfolded in fast action.The leading haptic scratched the posterior capsule bag, and the iol was drop into posterior segment of the eye.On the same day, a vitreoretinal surgery was performed to explant the lens and lens was exchanged with anterior chamber iol.Additional information has been requested.
Additional Manufacturer Narrative
Additional information was provided in d.10, h.3., h.6., and h.11.The product was not returned.Product history records were reviewed, and documentation indicated the product met release criteria.Qualified associated products were indicated.The product investigation could not identify a root cause for the reported complaint of lens unfolded fast and leading haptic scratched the eye.The lens was discarded by the reporting facility.No determination can be made without physical examination of the product.The instructions for use (ifu) instructs: using holding forceps, grasp the lens by the optic edge and gently place the lens anterior side up into the back of the ophthalmic viscosurgical devices (ovd)-filled cartridge.The lens should be inserted until the optic is a little more than half-way inside the cartridge.Use the holding forceps to gently push down on the lens, verifying that the lens is on the bottom surface of the cartridge.Using holding forceps, take the trailing haptic, and gently fold the haptic onto the anterior side of the optic.Slowly grip or push the optic edge to position the lens as far into the cartridge as the forceps will permit, while ensuring the lens remains on the bottom surface of the cartridge and the trailing haptic remains on the optic.Failure to follow these steps may cause the lens to advance incorrectly causing delivery issues and/or damage.The ifu instructs: follow the section regarding directions for use for information on the maximum allowed time for the iol to stay in the folded condition.Failure to adhere to manufacturer¿s recommendations may result in iol damage.Ifu note: during lens loading and insertion, do not allow the company iol to remain in a folded condition within the selected iol delivery system for more than 3 minutes prior to completing insertion into the capsular bag.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: 20304986
• Report Number: 1119421-2024-01908
• Device Sequence Number: 7745137
• Product Code: HQL
• UDI-Device Identifier: 00380652332712
• UDI-Public: (01)00380652332712(17)280827(11)230830(10)15698636
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: SA60WF
• Device Catalogue Number: SA60WF.225
• Device Lot Number: 15698636
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/27/2024
• Supplement Date Received by Manufacturer: 11/04/2024
• Initial Report FDA Received Date: 09/25/2024
• Supplement Report FDA Received Date: 12/02/2024
• Date Device Manufactured: 08/30/2023
• 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: ANTERIOR CHAMBER PMMA SINGLEPIECE IOL.; DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE.; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.; MONARCH III IOL DELIVERY SYSTEM, INJECTOR.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown