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

Model Number	SN60AT
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A health professional reported that two patients experienced a crack in the implanted intraocular lens (iol) implant after a procedure.The healthcare professional stated they checked the lens prior to implantation and there were no visible cracks.This record is for the first patient with the event occurring in the right eye on this date of event.Additional information has been requested and received stating that all surgeries were completed and the iols remain implanted so far.
Additional Manufacturer Narrative
This report originally filed as (b)(4).The product was not returned for analysis.Only photos were provided.Photos of the implanted lens were provided.There are lines/marks on the iol that have the appearance of a possible fold lines.No determination can be made from the photo.The complainant states the use of company cartridge and non-company viscoelastic which are not qualified to be used with the associated iol model.Video review: the only thing that immediately stood out is the cartridge being rinsed before the ovd is added and the amount of ovd being placed into the cartridge.It appears the ovd is only being placed at the loading area, which isn't sufficient.Ideally, the cartridge should be filled 2/3 with ovd".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 dfu, as the customer states the use of non-qualified combination.The use of non-qualified combination may result in delivery issues and/or damage.In addition to this, the video was provided as an example of the surgeon¿s technique.All product and batch history records are quality reviewed prior to product release.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 ; 8175514979
• MDR Report Key: 12859495
• Report Number: 9612169-2021-00268
• Device Sequence Number: 11835292
• Product Code: HQL
• UDI-Device Identifier: 00380650130358
• UDI-Public: 00380650130358
• 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: 2021
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/23/2021

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: 08/31/2025
• Device Model Number: SN60AT
• Device Catalogue Number: SN60AT.225
• Device Lot Number: 21282886
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2021
• Initial Report FDA Received Date: 11/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2020
• 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: ALCON BSS; MONARCH III CARTRIDGE D; MONARCH III INJECTOR; PE-HA-VISCO 2.0 %
• Patient Sex: Unknown