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

Model Number	SA60AT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Type of Reportable Event	Serious Injury
Event or Problem Description
A healthcare professional reported that at the time of implanting, when the lens enters the capsular bag, it is observed that he does not have a capsular suction, which is why a lens explant should be performed and a change made to a 3-piece lens.Additional information was requested and received, stating that the patient had recovered and that the surgery that was being performed at the time of the event was phacoemulsification.
Additional Manufacturer Narrative
The product was not returned for analysis.The root cause for the reported complaint could not be determined.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The product was returned for analysis and the reported complaint could not be confirmed.Iol returned in two pieces in the lens case.Solution was dried on both surfaces of the optic and haptics.Half of one haptic is broken/torn and not returned, the other haptic is broken/torn and is returned.The optic is split in two, cracked/fractured and scratched/marked-rejectable.The complainant indicates the use of non company as a viscoelastic and company cartridge, both of these items are not qualified to be used with the associated iol model.We are unable to determine the root cause for the reported complaint.Damage was observed to the iol.Customer indicated using non-qualified ovd and cartridge choice.The use of an unqualified combination may cause damage to the iol and potential complications during the implantation process.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: 17172964
• Report Number: 9612169-2023-00470
• Device Sequence Number: 7338066
• Product Code: HQL
• UDI-Device Identifier: 00380652555791
• UDI-Public: 00380652555791
• 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): 10/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: SA60AT
• Device Catalogue Number: SA60AT.195
• Device Lot Number: 25518523
• 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: 05/24/2023
• Supplement Date Received by Manufacturer: 10/06/2023
• Initial Report FDA Received Date: 06/21/2023
• Supplement Report FDA Received Date: 10/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2022
• 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: BIOVISC VISCOELASTIC.; MONARCH III CARTRIDGE D.; MONARCH INJECTOR UNSPECIFIED.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown