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

Model Number	SA60AT
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A non-healthcare professional reported that during the intraocular lens (iol) implant procedure, ol presented a defect in the optical center that would compromise the visual quality.Iol was removed from the eye and a new iol was implanted.Additional information has been requested.
Additional Manufacturer Narrative
A sample device was not returned for analysis.Complaint history and product history records could not be reviewed because the reporter did not provide a lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
D.3.Product manufacturing site updated due to receipt of serial number.G.9.Manufacturer report number corrected and reported under mdr# 9612169-2023-00526 (2277898).No further reports will be provided under this report.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Only photo was returned.Photo provided shows lens on black background.The intraocular lens (iol) is in 2 pieces.Reported damage to the lens cannot be confirmed from the photo.The complainant indicates the use of company cartridge, which is not qualified for use with associated iol model.Based on our observation of the attached photo, the iol is presented on an unknown background and is cut in a half.The observed condition is consistent with lens having been explanted.A definitive determination of the reported damage cannot be made without the evaluation of the physical product; however, based on the information provided by the customer, the most likely root cause is failure to follow instruction for use (ifu), as the surgeon states the use of non-qualified combination.The use of non-qualified combinations may result in delivery issues and/or damage.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 WV 00000 ; EI 00000
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork WV 00000 ; EI 00000
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 17032694
• Report Number: 1119421-2023-01012
• Device Sequence Number: 7040241
• Product Code: HQL
• UDI-Device Identifier: 00380652555807
• UDI-Public: 00380652555807
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/22/2023

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: 06/26/2026
• Device Model Number: SA60AT
• Device Catalogue Number: SA60AT.200
• Device Lot Number: 25226695
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/03/2023
• Supplement Date Received by Manufacturer: 06/14/2023; 07/25/2023
• Initial Report FDA Received Date: 05/31/2023
• Supplement Report FDA Received Date: 07/12/2023; 08/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2021
• 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: MONARCH CARTRIDGE D; VISCOAT
• Patient Sex: Female