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

Model Number	SA60AT
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	03/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A health care professional reported that during surgery, they have noticed that the lens was cracked (possibly due to cartridge).Subsequently the lens was removed during initial procedure and completed with another lens.Patient had an enlargement of incision.Additional information has been requested.
Additional Manufacturer Narrative
A product 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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Additional Manufacturer Narrative
10-dec-2024 09:40 am additional information has been provided in h.3., h.6., and h.11 the product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.A non-qualified company cartridge and non-qualified viscoelastic were indicated.The company lens is only qualified for the company (b) and (c) cartridge.A handpiece was indicated that would be qualified for this lens when used with a qualified cartridge and viscoelastic combination.The root cause for the reported complaint was most likely related to a failure to follow the ifu.A non-qualified cartridge and non-qualified viscoelastic were used.The ifu instructs: company foldable intraocular lens (iol) are qualified for use with an company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The instruction for use (ifu) instructs that an 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 was provided the lens with 21.0 diopter lens was removed and replaced.The replacement lens information was not provided.File will be reopened if new information is received.The manufacturer internal reference number is: (b)(4).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• Brand Name: ACRYSOF 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: 20631997
• Report Number: 1119421-2024-02161
• Device Sequence Number: 8144462
• Product Code: HQL
• UDI-Device Identifier: 00380652555821
• UDI-Public: (01)00380652555821(17)280715(11)230718(10)15683542
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 01/03/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: SA60AT
• Device Catalogue Number: SA60AT.210
• Device Lot Number: 15683542
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/09/2024
• Supplement Date Received by Manufacturer: 12/10/2024
• Initial Report FDA Received Date: 11/07/2024
• Supplement Report FDA Received Date: 01/03/2025
• Date Device Manufactured: 07/18/2023
• 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 VISCOELASTIC SYSTEM; MONARCH III IOL, CARTRIDGE D; MONARCH III IOL, INJECTOR; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Outcome Attributed to Adverse Event: Other
• Patient Age: 68 YR
• Patient Sex: Male