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

Model Number	SA60WF
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.The product history and batch records were reviewed and documentation indicated the product met release criteria.The cartridge product history record could not be reviewed because facility did not provide a lot number or any identification traceable to the manufacturing documentation.The product investigation could not identify a root cause.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A healthcare professional reported that during cataract surgery with intraocular lens (iol) implantation, lens had a linear crack from the middle up to the optic haptic junction which was noted upon insertion.There was no difficulty when folding and inserting the iol.The surgeon decided to leave the iol inside the patient¿s eye as patient had acute macular degeneration.Additional information has been requested.
Additional Manufacturer Narrative
Correction information was provided in h.6.- on initial mdr the method code of b17 was an error.It should have been b20 on the original mdr.The product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.Qualified associated products were indicated.The product investigation could not identify a root cause.The lens was left implanted.The instruction 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 device (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.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: 19891130
• Report Number: 1119421-2024-01503
• Device Sequence Number: 7796298
• Product Code: HQL
• UDI-Device Identifier: 00380652332682
• UDI-Public: 00380652332682
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: SA60WF
• Device Catalogue Number: SA60WF.210
• Device Lot Number: 15690593
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/08/2024
• Supplement Date Received by Manufacturer: 08/29/2024
• Initial Report FDA Received Date: 08/02/2024
• Supplement Report FDA Received Date: 09/26/2024
• Date Device Manufactured: 08/08/2023
• 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: DUOVISC OVD; DUOVISC VISCOELASTIC SYSTEM; MONARCH III IOL , INJECTOR; MONARCH III IOL CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR
• Patient Sex: Unknown