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

Model Number	SA60AT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/05/2025
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).
Event or Problem Description
A health care professional during surgery noticed that the lens appeared with poor inferior haptics, which was evident at the time of lens injection.Subsequently the lens was removed during initial procedure and completed with another lens with same power.The patient was in good condition.Additional information has been requested.
Additional Manufacturer Narrative
Additional information has been provided in d.9.,h.3., h.6., and h.11 the product was returned for analysis and the reported damage to the iol (intraocular lens) was observed.Iol returned in three pieces adhered to one another positioned incorrectly in the iol case.Solution is dried on the iol.One haptic is broken and adhered to a segment of the iol optic, the other haptic is broken and not returned.The optic is torn/split-cut dividing the iol optic in two pieces adhered to each other.The iol optic is scratched/marked-rejectable.We are unable to determine the root cause for the reported complaint poor inferior haptics (in and out).The iol was returned in three segments, which is consistent with lens having been explanted.The product was subject to handling and the reported damage was highlighted post implantation.The reported complaint is lacking in relevant information such as associated products (cartridge, handpiece, viscoelastic) used to complete a thorough investigation.Due to the lack of information, we are unable to verify if the product contributed to the event.In addition to this, all iols are 100 percent cosmetically inspected as per approved manufacturing procedures and the observed lens damage/condition would not meet our current release criteria.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).

• 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: 21863968
• Report Number: 9612169-2025-00629
• Device Sequence Number: 4721202
• Product Code: HQL
• UDI-Device Identifier: 00380652555869
• UDI-Public: (01)00380652555869(17)290506(11)240508(10)25845560
• 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): 07/04/2025

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.230
• Device Lot Number: 25845560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/20/2025
• Supplement Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 04/18/2025
• Supplement Report FDA Received Date: 07/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2024
• 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
• Patient Age: 29 YR
• Patient Sex: Female