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

Model Number	SN60WF
Medical Device Problem Codes	Break (1069); Failure to Advance (2524)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
An ophthalmologist reported that during a cataract extraction with an intraocular lens (iol) implant procedure, this event occurred half way loading into the eye, but got stuck before full insertion.The iol and nozzle have contact with patient, the nozzle and leading haptic was inside the ac, they pull it out shortly cause the lens could not dislodge.Haptic broken during lens dialling in the company injector.Surgery was completed with another company lens.Additional information was requested, but no further information is available.
Additional Manufacturer Narrative
A sample device was not returned for analysis.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).
Additional Manufacturer Narrative
The product was returned for analysis and the reported complaint was observed.Company cartridge returned.Iol returned pressed down on two posts of the iol case base resulting in iol deformation.Solution was observed on the iol.One haptic was broken/torn and not returned, the other haptic is bent.The optic is bent, cracked/split almost in two and scratched/marked-rejectable.Unable to conduct dimensional testing due to condition of returned sample.The reporter states a specific company cartridge was used so the company other model cartridge will not be evaluated.The product investigation could not identify the root cause for the reported complaint "haptic broken, lens stuck" as the lens was returned outside the device.Due to this, we are unable to confirm lens and haptic position for advancement and determine a root cause.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 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: 16333053
• Report Number: 9612169-2023-00112
• Device Sequence Number: 6789566
• Product Code: HQL
• UDI-Device Identifier: 00380655095690
• UDI-Public: 00380655095690
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2023

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 Expiration Date: 03/02/2026
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.140
• Device Lot Number: 25160939
• 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: 01/13/2023
• Supplement Date Received by Manufacturer: 05/31/2023
• Initial Report FDA Received Date: 02/09/2023
• Supplement Report FDA Received Date: 06/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DISCOVISC; MONARCH III IOL, CARTRIDGE D; MONARCH, INJECTOR, UNSPECIFIED
• Patient Sex: Unknown