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	Capsular Bag Tear (2639)
Date of Event	08/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was returned for analysis and the reported "fractured haptic" was observed.Intraocular lens (iol) returned positioned incorrectly in the lens case base.Solution is dried on both surfaces of the optic and haptics.The optic is cracked/fractured near the gusset area which could be interpreted as the reported complaint "fractured haptic".We are unable to determine the root cause for the reported complaint "fractured haptic, in and out, rupture of the posterior capsule, anterior vitrectomy".The iol was subject to handling, the lens was explanted.The reported complaint is lacking in relevant information such as associated products used to complete a thorough investigation.In addition to this, all iols are 100 percent cosmetically inspected as per approved manufacturing procedures and the observed lens damage would not meet our current release criteria.Based on these investigation findings, we are unable to verify if the iol contributed to the event.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A healthcare professional reported that during a cataract surgery with intraocular lens (iol) implantation procedure, the haptic fractured.The lens was removed during the initial procedure and replaced with another lens.There was a rupture of the posterior capsule during the process.Additional information was received stating that anterior vitrectomy was performed, and an unspecified three-piece lens was implanted.Patient was prescribed with antibiotic and steroid anti-inflammatory as a post-surgical management.Patient's outcome was recovered.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information was provided in e.1., h.3., h.6.And h.11.The product was returned for analysis and the reported "fractured haptic" was observed.Intraocular lens (iol) returned positioned incorrectly in the lens case base.Solution is dried on both surfaces of the optic and haptics.The optic is cracked/fractured near the gusset area which could be interpreted as the reported complaint "fractured haptic".The reporter stated the use of non-company viscoelastic; this is not qualified for use with the associated iol model.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 viscoelastic.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: 20249597
• Report Number: 9612169-2024-00911
• Device Sequence Number: 7291965
• Product Code: HQL
• UDI-Device Identifier: 00380652555869
• UDI-Public: (01)00380652555869(17)290312(11)240314(10)25819119(21)25819119065
• 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,Followup
• Report Date (Section B): 11/25/2024

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.230
• Device Lot Number: 25819119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/20/2024
• Supplement Date Received by Manufacturer: 09/19/2024; 10/30/2024
• Initial Report FDA Received Date: 09/18/2024
• Supplement Report FDA Received Date: 10/18/2024; 11/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 IOL DELIVERY SYSTEM, INJECTOR.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Female