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

Model Number	SN60WF
Medical Device Problem Codes	Crack (1135); Unintended Ejection (1234); Scratched Material (3020); Failure to Eject (4010)
Health Effect - Clinical Codes	Capsular Bag Tear (2639); Zonular Dehiscence (2698); Insufficient Information (4580)
Date of Event	11/29/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A other healthcare professional reported that during an intraocular lens (iol) implant procedure, the iol was removed from the wagon wheel and placed in cartridge.The iol was fine when removed from the wagon wheel.After implantation scratches / cracks were found on the lens.Iol was explanted and replaced with new iol.Additional information has been requested.
Additional Manufacturer Narrative
Evaluation summary: investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The product was returned for analysis and the reported complaint was observed.Iol returned in sample container along with lens case lid.The iol is immersed in solution.Both haptics intact.The optic is cracked/fractured, with a piece missing and scratched/marked-rejectable.Photo shows implanted iol.The iol has multiple lines/marks over the iol optic.The complainant indicates use of protectalon 1,4% as a viscoelastic, which is not qualified to be used 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 (ifu), as the surgeon states the use of non-qualified ovd.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).
Event or Problem Description
Additional information has been received that the lens entered the eye at high speed and last third of the lens was still in the injector.Due to the high speed the zonular lysis and rupture of the anterior inferior capsule occurred.The new lens was implanted in the sulcus after anterior vitrectomy.The hospital stay was extended.The lens was well positioned.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ NATURAL 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: 18417477
• Report Number: 9612169-2023-00965
• Device Sequence Number: 15490204
• Product Code: HQL
• UDI-Device Identifier: 00380655093269
• UDI-Public: 00380655093269
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/04/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.235
• Device Lot Number: 25677484
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/04/2023
• Supplement Date Received by Manufacturer: 01/15/2024; 03/07/2024
• Initial Report FDA Received Date: 12/29/2023
• Supplement Report FDA Received Date: 02/09/2024; 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2023
• 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 II LOADING FORCEPS; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; PROTECTALON 1,4%
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female