MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. ACRYSOF SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number	SA60AT
Medical Device Problem Codes	Failure to Deliver (2338); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
A health care professional reported that during an intraocular lens (iol) implant procedure, lens was mounted on a cartridge.When the injector with the cartridge was inserted into the patients eye, resistance was noted when entering the chamber and when the lens comes out it was seen to be broken.Another lens of the same diopter was requested and when assembling it again, the lens mounted on the same cartridge was fractured.Additional information was received and stated, there was no patient harm and patient was recovered.
Additional Manufacturer Narrative
Additional information was provided in d.9.,d.10.,h.3.,h.6 and h.11.The product was returned for analysis and the reported complaint was observed.Intra ocular lens (iol) returned positioned correctly in the iol case.Solution is dried on the iol.One haptic is broken or torn and is returned, the other haptic is scratched or marked rejectable.The optic is cracked, chipped and scratched or marked rejectable.The used company cartridge was returned.Viscoelastic was observed in the cartridge.The cartridge had a large aneurysm on the right side of the tip.The tip had heavy stress.The cartridge had evidence of placement into a handpiece.The company cartridge was cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results.The tip damage would indicate the lens plunger were not in acceptable positions for advancement.It was also indicated the cartridge was reused with the second iol.The complainant states the use of company cartridge which is not qualified for use with associated model, this is not a qualified company product combination.While we are unable to determine the origin of the reported complaint, our observations reasonably suggest that it is not manufacturing related.Based on the information provided by the customer, the most likely root cause is failure to follow instructions for use (ifu), as the surgeon states the use of non qualified combination.The use of an unqualified combination may cause damage to the iol and potential complications during the implantation process.It was also indicated that the cartridge was reused with the second iol.Company cartridge is a single use product.The ifu instructs: do not reuse the cartridge.The cartridge is for single use only.Reuse of this single use device may result in serious injury, such as serious infection.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 LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 21730548
• Report Number: 9612169-2025-00497
• Device Sequence Number: 11789457
• Product Code: HQL
• UDI-Device Identifier: 00380652555890
• UDI-Public: (01)00380652555890(17)290603(11)240605(10)25861534
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 05/26/2025

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 Model Number: SA60AT
• Device Catalogue Number: SA60AT.245
• Device Lot Number: 25861534
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/03/2025
• Supplement Date Received by Manufacturer: 05/02/2025
• Initial Report FDA Received Date: 03/31/2025
• Supplement Report FDA Received Date: 05/26/2025
• Date Device Manufactured: 06/05/2024
• 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 III IOL DELIVERY SYSTEM, CARTRIDGE D; UNSPECIFIED CARTRIDGE; UNSPECIFIED INJECTOR
• Patient Age: 67 YR
• Patient Sex: Male