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

Model Number	MA60AC
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lens was returned positioned incorrectly in the lens case in the lens carton.Viscoelastic and a small amount of blood was dried on the lens.The optic was cut into two pieces.The optic edge was broken (this area contained one haptic).The other haptic was bent in the distal area around a post of the lens case due to being replaced incorrectly into the lens case for return.The optic was torn (still attached) in the area that included the haptic insertion area of the bent haptic.The lens was cleaned with klrp (klotho-related protein klrp) to further evaluate.The optic anterior was scratched on the anterior and posterior surface near the edge.The posterior optic portion was scratched near the optic center.The optic edge was split from edge inward.Product history records were reviewed and documentation indicated the product met release criteria.A qualified cartridge and handpiece were used.A non-qualified viscoelastic was used.The reported scratch damage was observed.The root cause may be related to a failure to follow the ifu.A non-qualified viscoelastic was used.The ifu instructs: company foldable iols are qualified for use with a company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The ifu instructs that a company qualified delivery system and viscoelastic combination should be used.The use of an unqualified combination may cause damage to the lens and potential complications during the implantation process.Information indicated that the company lens with 26.5 diopter lens was removed and replaced with another company lens with diopter lens.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A facility representative reported that during surgery, once the lens was injected a scratch was noticed.It was cut out and a new lens placed.There was patient contact.Procedure was completed on the same day.No patient harm.Additional information has been requested.

• Brand Name: ACRYSOF MULTIPIECE IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 22070537
• Report Number: 1119421-2025-01462
• Device Sequence Number: 9374696
• Product Code: HQL
• UDI-Device Identifier: 00380652552653
• UDI-Public: (01)00380652552653(17)260524(11)210526(10)15207269
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/22/2025

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: 05/24/2026
• Device Model Number: MA60AC
• Device Catalogue Number: MA60AC.265
• Device Lot Number: 15207269
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2025
• Initial Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2021
• 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 II IOL, CARTRIDGE B.; MONARCH III IOL, INJECTOR.; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE.
• Patient Sex: Unknown