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

Model Number	SA60WF
Medical Device Problem Codes	Break (1069); Failure to Eject (4010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample device 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.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported that during a cataract extraction with intraocular lens (iol) implant procedure, there was a rupture of loop, that lead to the impossibility of implantation.It was reported that the breaking of the lens caused by the need to remove the lens stuck in the surgical tunnel, as during the implantation the patient with an uncontrolled movement moved the head during the implantation phase, freeing the surgical breach from the injector, that leads to the incarceration of the optic body in the surgical tunnel.The surgeon removed the lens to reload it in the company cartridge, but he broke a loop by pulling.He replaced the lens, which in any case did not enter the anterior chamber, and completed the surgery without any consequences for the patient.Additional information has been requested and received stated that optic plate was not damaged.
Additional Manufacturer Narrative
The product was not returned for analysis.The file states, "the breaking of the lens was caused by the need to remove the lens stuck in the surgical tunnel.As during the implantation, the patient with an uncontrolled movement moved the head, during the implantation phase.Freeing the surgical breach from the injector.The consequence, was the incarceration of the optic body in the surgical tunnel.The surgeon removed the lens to reload it in the cartridge, but he broke a loop by pulling".The root cause for the reported complaint appears to be a coincidental event that was unrelated to product.As it was reported by hcp, that "the breaking of the lens was caused by the need to remove the lens stuck in the surgical tunnel.As during, the implantation the patient with an uncontrolled movement moved the head, during the implantation phase.Freeing the surgical breach from the injector.The consequence, was the incarceration of the optic body in the surgical tunnel".Based on this information, the product did not cause/contribute to the event.It was also reported, that "the surgeon removed the lens to reload it in the company cartridge, but he broke a loop by pulling".The root cause for the broken haptic appears to related to a failure to follow the ifu.The ifu instructs: "do not reuse the iol.This device is for single use only".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
Iol returned loose in a non-company sealed pouch.Solution and blood is dried on both surfaces of the optic and one haptic.One haptic is broken/torn and not returned, the other is broken/torn and is returned.The optic is chipped and scratch/marked-rejectable.The complaint is unrelated to the product.Investigation results remains unchanged.No updates required.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF ASPHERIC UV ABSORBING 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: 14538701
• Report Number: 9612169-2022-00238
• Device Sequence Number: 17492262
• Product Code: HQL
• UDI-Device Identifier: 00380652332682
• UDI-Public: 00380652332682
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/21/2022

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: SA60WF
• Device Catalogue Number: SA60WF.210
• Device Lot Number: 25326776
• 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: 05/03/2022
• Supplement Date Received by Manufacturer: 07/28/2022; 09/23/2022
• Initial Report FDA Received Date: 05/29/2022
• Supplement Report FDA Received Date: 08/23/2022; 10/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2021
• 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 Sex: Male